Food, drugs, devices › B. Braun Medical, Inc.
Device recall: CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 Connection device used by physicians to provide various
FDA enforcement event 80811 is a device recall by B. Braun Medical, Inc. of Allentown, PA, initiated 20 Jul 2018 and classified Class II, with 93 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 13 May 2020. Initiation: voluntary: firm initiated. B. Braun Medical, Inc. has 90 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
B. Braun Medical, Inc., Allentown, PA.
Reason for recall
"The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed."
Distribution
"Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3313-2018 | CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 600 | Class II | Terminated | 10 Oct 2018 |
| Z-3314-2018 | CNBFX350O CONTIPLEX CONT NERVE BLOCK, Material Number 331670 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 108 | Class II | Terminated | 10 Oct 2018 |
| Z-3315-2018 | CNBFX350C CONTIPLEX CONT NERVE BLOCK, Material Number 331672 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 300 | Class II | Terminated | 10 Oct 2018 |
| Z-3316-2018 | CONTIPLEX TUOHY ULTRA 2 IN CONT. PNB SET, Material Number 331673 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 168 | Class II | Terminated | 10 Oct 2018 |
| Z-3317-2018 | CNB200T CONTIPLEX TUOHY SET 2 IN, Material Number 331691 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 5460 | Class II | Terminated | 10 Oct 2018 |
| Z-3318-2018 | CONTIPLEX TUOHY ULTRA 4 IN CNB400TU, LF, Material Number 331691 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 468 | Class II | Terminated | 10 Oct 2018 |
| Z-3319-2018 | CONTIPLEX TUOHY SET, 18GX4", 1.3X100MM, Material Number 331693 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 10944 | Class II | Terminated | 10 Oct 2018 |
| Z-3320-2018 | CONTIPLEX TUOHY SET, 18GX6", 1.3X150MM, Material Number 331694 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 864 | Class II | Terminated | 10 Oct 2018 |
| Z-3321-2018 | CONTIPLEX TUOHY SET, 18GX11/2X 1,3X40MM, Material Number 331695 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 1848 | Class II | Terminated | 10 Oct 2018 |
| Z-3322-2018 | CNB200S CONTIPLEX INSULATED TUOHY NDL, Material Number 331697 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 144 | Class II | Terminated | 10 Oct 2018 |
| Z-3323-2018 | CNB200TK CONTIPLEX CONT NERVE BLOCK, Material Number 331701 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 1370 | Class II | Terminated | 10 Oct 2018 |
| Z-3324-2018 | CNB400TK CONTIPLEX CONT NERVE BLOCK, Material Number 331706 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 4510 | Class II | Terminated | 10 Oct 2018 |
| Z-3325-2018 | SCNB4TK CONT STIM W/4 INCH INSUL TUOHY, Material Number 331756 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 1020 | Class II | Terminated | 10 Oct 2018 |
| Z-3326-2018 | CONT STIM BASIC KIT W/2 IN INSUL TUOHY, Material Number 331757 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 120 | Class II | Terminated | 10 Oct 2018 |
| Z-3327-2018 | CONT STIM BASIC KIT W/4 IN INSUL TUOHY, Material Number 331758 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 430 | Class II | Terminated | 10 Oct 2018 |
| Z-3328-2018 | CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 190 | Class II | Terminated | 10 Oct 2018 |
| Z-3329-2018 | CONTI ECHO CT W/2IN TUOHY ULTRA 360 SET, Material Number 331767 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 590 | Class II | Terminated | 10 Oct 2018 |
| Z-3330-2018 | CE17TKFCY 17GA SAFETY TUOHY NEEDLE TRAY, Material Number 332075 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 3120 | Class II | Terminated | 10 Oct 2018 |
| Z-3331-2018 | CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 60760 | Class II | Terminated | 10 Oct 2018 |
| Z-3332-2018 | CE17TKFCPS EPIDURAL FULL TRAY, Material Number 332078 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration… | 25020 | Class II | Terminated | 10 Oct 2018 |
| Z-3333-2018 | CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 69750 | Class II | Terminated | 10 Oct 2018 |
| Z-3334-2018 | CE17TKFSA FULL TRAY W/17G TUOHY 19G SPRW, Material Number 332080 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 2250 | Class II | Terminated | 10 Oct 2018 |
| Z-3335-2018 | CE18TKST CONT EPID W/SOFT TIP, Material Number 332081 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration… | 30530 | Class II | Terminated | 10 Oct 2018 |
| Z-3336-2018 | CE17TKST CONT EPID W/SOFT TIP, Material Number 332082 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration… | 12230 | Class II | Terminated | 10 Oct 2018 |
| Z-3337-2018 | CE18HKST CONT EPID 20G SOFTIP, Material Number 332084 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration… | 14520 | Class II | Terminated | 10 Oct 2018 |
| Z-3338-2018 | CE17TKF PERIFIX CONTIN. EPIDURAL TRAY, Material Number 332086 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 17160 | Class II | Terminated | 10 Oct 2018 |
| Z-3339-2018 | CE17TKFPS PERIFIX FX CONT. EPID TRAY-LF, Material Number 332087 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 3430 | Class II | Terminated | 10 Oct 2018 |
| Z-3340-2018 | CE17TKFSDT EPID TRAY W/17GA FIXED WING, Material Number 332093 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 2420 | Class II | Terminated | 10 Oct 2018 |
| Z-3341-2018 | CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 1040 | Class II | Terminated | 10 Oct 2018 |
| Z-3342-2018 | CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 3130 | Class II | Terminated | 10 Oct 2018 |
| Z-3343-2018 | CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF, Material Number 332097 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 93140 | Class II | Terminated | 10 Oct 2018 |
| Z-3344-2018 | CE17TKFS EPIDURAL TRAY, Material Number 332098 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 24810 | Class II | Terminated | 10 Oct 2018 |
| Z-3345-2018 | CNB200TKU NON-STIM CATH FULL KIT, Material Number 332127 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 880 | Class II | Terminated | 10 Oct 2018 |
| Z-3346-2018 | CNB400TKU NON-STIM CATH FULL KIT, Material Number 332128 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 2740 | Class II | Terminated | 10 Oct 2018 |
| Z-3347-2018 | CONTIPLEX CONT 4 IN TUOHY ULTRA PNB TRAY, Material Number 332129 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 340 | Class II | Terminated | 10 Oct 2018 |
| Z-3348-2018 | CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY, Material Number 332143 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 2090 | Class II | Terminated | 10 Oct 2018 |
| Z-3349-2018 | CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 1350 | Class II | Terminated | 10 Oct 2018 |
| Z-3350-2018 | CE18T CONT EPIDURAL SET, Material Number 332200 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 10500 | Class II | Terminated | 10 Oct 2018 |
| Z-3351-2018 | CE18TIN CONT EPIDURAL SET LF, Material Number 332201 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 372 | Class II | Terminated | 10 Oct 2018 |
| Z-3352-2018 | CE17T CONT EPIDURAL SET, Material Number 332202 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 504 | Class II | Terminated | 10 Oct 2018 |
| Z-3353-2018 | CE17TO CONT EPIDURAL SET LF, Material Number 332204 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 612 | Class II | Terminated | 10 Oct 2018 |
| Z-3354-2018 | CE18HKCD CONT EPIDURAL TRAY, Material Number 332206 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 2790 | Class II | Terminated | 10 Oct 2018 |
| Z-3355-2018 | CE18H CONT EPIDURAL SET, Material Number 332210 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 1632 | Class II | Terminated | 10 Oct 2018 |
| Z-3356-2018 | CE18TKCD CONT EPIDURAL TRAY, Material Number 332211 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 10470 | Class II | Terminated | 10 Oct 2018 |
| Z-3357-2018 | CE17TKCDLS CONT EPIDURAL TRAY, Material Number 332212 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration… | 8210 | Class II | Terminated | 10 Oct 2018 |
| Z-3358-2018 | CE18TKDP CONT EPID/DURAPREP, Material Number 332215 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 11010 | Class II | Terminated | 10 Oct 2018 |
| Z-3359-2018 | CE18TKPS CONT EPIDURAL TRAY (LF), Material Number 332216 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 13890 | Class II | Terminated | 10 Oct 2018 |
| Z-3360-2018 | CE18TKCD10L 18GA TUOHY/10CC GLAS, Material Number 332217 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 11130 | Class II | Terminated | 10 Oct 2018 |
| Z-3361-2018 | CE18TBLS CONT EPIDURAL TRAY, Material Number 332219 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 8380 | Class II | Terminated | 10 Oct 2018 |
| Z-3362-2018 | CE18TK ACCU-BLOC PERIFIX KIT, Material Number 332220 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 63980 | Class II | Terminated | 10 Oct 2018 |
| Z-3363-2018 | CE17TK CONT EPIDURALTUOHY, Material Number 332221 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 2790 | Class II | Terminated | 10 Oct 2018 |
| Z-3364-2018 | CE18TB CONT EPIDURAL TRAY, Material Number 332222 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 57820 | Class II | Terminated | 10 Oct 2018 |
| Z-3365-2018 | CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 24850 | Class II | Terminated | 10 Oct 2018 |
| Z-3366-2018 | CE17TB CONT EPIDURAL TUOHY, Material Number 332224 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 12930 | Class II | Terminated | 10 Oct 2018 |
| Z-3367-2018 | CE17TKCD CONT EPIDURAL ANESTHESIA KIT, Material Number 332229 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 1370 | Class II | Terminated | 10 Oct 2018 |
| Z-3368-2018 | CE18HK ACCU-BLOC PERIFIX KIT, Material Number 332230 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of… | 3490 | Class II | Terminated | 10 Oct 2018 |
| Z-3369-2018 | CE18HKPS CONTIN. EPIDURAL TRAY, Material Number 332231 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration… | 2040 | Class II | Terminated | 10 Oct 2018 |
| Z-3370-2018 | CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 2400 | Class II | Terminated | 10 Oct 2018 |
| Z-3371-2018 | CE17TF PERIFIX FX CONTIN. EPIDURAL SET, Material Number 332234 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | 1032 | Class II | Terminated | 10 Oct 2018 |
| Z-3372-2018 | CE17TOD CONT EPIDURAL TRAY LF, Material Number 332235 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration… | 1980 | Class II | Terminated | 10 Oct 2018 |
Showing 60 of 93 product records; the FDA enforcement report lists all of them.
Context
92%of 2018 device events are Class II1,074 events that year
93product records in this eventfirm median: 1
90events on this register for the firm
Other enforcement events for B. Braun Medical, Inc.
All 90 events for B. Braun Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 May 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.