Recall Register

Device recall: FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B

Class II FDA enforcement event 84726. Recall start date: . Status in the FDA record: Terminated. Termination date: .

Reason for recall, in the words of FDA

There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.

Class II, in the words of FDA

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

Arrow International Inc started this device recall on 15 Jan 2020. The firm address in the FDA record is in Reading, PA. FDA put the recall in Class II. FDA event 84726 has 49 product records. The first FDA enforcement report date is 19 Feb 2020. The record gives the status Terminated, with the termination date 17 Mar 2023.

FDA enforcement reportThe 49 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

The products were distributed to the following US states: AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA,…

Recalling firm

Arrow International Inc, Reading, PA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

49 product records in the event.

FDA event 84726: product records
Recall numberProductQuantityClassStatusReport date
Z-1170-2020FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B343105 totalClass IITerminated19 Feb 2020
Z-1171-2020FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E343,105 totalClass IITerminated19 Feb 2020
Z-1172-2020FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501343,105 totalClass IITerminated19 Feb 2020
Z-1173-2020EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B343,105 totalClass IITerminated19 Feb 2020
Z-1174-2020FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH343,105 totalClass IITerminated19 Feb 2020
Z-1175-2020TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1343,105 totalClass IITerminated19 Feb 2020
Z-1176-2020FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM343,105 totalClass IITerminated19 Feb 2020
Z-1177-2020FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500343,105 totalClass IITerminated19 Feb 2020
Z-1178-2020FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BID343,105 totalClass IITerminated19 Feb 2020
Z-1179-2020FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1343,105 totalClass IITerminated19 Feb 2020
Z-1180-2020FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH343,105 totalClass IITerminated19 Feb 2020
Z-1181-2020Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY343,105 totalClass IITerminated19 Feb 2020
Z-1182-2020FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID343,105 totalClass IITerminated19 Feb 2020
Z-1183-2020FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1343,105 totalClass IITerminated19 Feb 2020
Z-1184-2020FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH343,105 totalClass IITerminated19 Feb 2020
Z-1185-2020FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC343,105 totalClass IITerminated19 Feb 2020
Z-1186-2020EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO343,105 totalClass IITerminated19 Feb 2020
Z-1187-2020EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN343,105 totalClass IITerminated19 Feb 2020
Z-1188-2020EPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTEL343,105 totalClass IITerminated19 Feb 2020
Z-1189-2020EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH343,105 totalClass IITerminated19 Feb 2020
Z-1190-2020EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO343,105 totalClass IITerminated19 Feb 2020
Z-1191-2020EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXL343,105 totalClass IITerminated19 Feb 2020
Z-1192-2020EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-CHH343,105 totalClass IITerminated19 Feb 2020
Z-1193-2020FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220343,105 totalClass IITerminated19 Feb 2020
Z-1194-2020EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI343,105 totalClass IITerminated19 Feb 2020
Z-1195-2020EPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BO343,105 totalClass IITerminated19 Feb 2020
Z-1196-2020FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P343,105 totalClass IITerminated19 Feb 2020
Z-1197-2020EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04343,105 totalClass IITerminated19 Feb 2020
Z-1198-2020EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10343,105 totalClass IITerminated19 Feb 2020
Z-1199-2020EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12343,105 totalClass IITerminated19 Feb 2020
Z-1200-2020EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC343,105 totalClass IITerminated19 Feb 2020
Z-1201-2020FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B343,105 totalClass IITerminated19 Feb 2020
Z-1202-2020FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS343,105 totalClass IITerminated19 Feb 2020
Z-1203-2020FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E343,105 totalClass IITerminated19 Feb 2020
Z-1204-2020EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB343,105 totalClass IITerminated19 Feb 2020
Z-1205-202010 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501343,105 totalClass IITerminated19 Feb 2020
Z-1206-2020FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP343,105 totalClass IITerminated19 Feb 2020
Z-1207-2020FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP343,105 totalClass IITerminated19 Feb 2020
Z-1208-2020EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU343,105 totalClass IITerminated19 Feb 2020
Z-1209-2020FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK343,105 totalClass IITerminated19 Feb 2020
Z-1210-2020EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU343,105 totalClass IITerminated19 Feb 2020
Z-1211-2020FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1343,105 totalClass IITerminated19 Feb 2020
Z-1212-2020FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME343,105 totalClass IITerminated19 Feb 2020
Z-1213-2020Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI343,105 totalClass IITerminated19 Feb 2020
Z-1214-2020EPIDURAL CATHETERIZATION KIT, Product Code UR-05501343,105 totalClass IITerminated19 Feb 2020
Z-1215-2020EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP343,105 totalClass IITerminated19 Feb 2020
Z-1216-2020EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1343,105 totalClass IITerminated19 Feb 2020
Z-1217-2020FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220343,105 totalClass IITerminated19 Feb 2020
Z-1218-2020EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN343,105 totalClass IITerminated19 Feb 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020
916
Share of these events in Class II
93%
Product records in this event
49Median of the firm: 1
Events of the firm on the register
93

Other events of the firm

Other FDA enforcement events of Arrow International Inc
InitiatedProduct (first record)TypeClassRecords
26 Jul 2024Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not IncDeviceClass II1
29 Apr 2024Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWSDeviceClass I3
12 Feb 2024ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMDeviceClass I1
10 Aug 2023Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, RDeviceClass I4
10 Aug 2023Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascularDeviceClass II2
19 May 2023ARROW Endurance Extended Dwell Peripheral Catheter SystemDeviceClass I1
27 Oct 2022Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducerDeviceClass I2
17 Oct 2022Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pumpDeviceClass I31
14 Sep 2022ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHDeviceClass II1
5 May 2022Arrow Three-Lumen CVCDeviceClass II1

Arrow International Inc: all 93 events

Official channels

Cite this page

Recall Register. FDA enforcement event 84726. https://recallregister.com/fda/ii/84726/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA device enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: The products were distributed to the following US states: AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA,…
What quantity of product is in FDA event 84726?
The event has 49 product records. The first record gives this quantity: 343105 total
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?
93% of the 916 device events that started in 2020 are in Class II.