Device recall: ANCILLARY PACK-LF. Sterile Procedural Tray.
Class II FDA enforcement event 91386. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
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
MEDLINE INDUSTRIES, LP - Northfield started this device recall on 17 Nov 2022. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 91386 has 38 product records. The first FDA enforcement report date is 15 Feb 2023. The record gives the status Ongoing.
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.
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
38 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1060-2023 | ANCILLARY PACK-LF. Sterile Procedural Tray. | 48 cases (96 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1061-2023 | TRACH PACK. Sterile Procedural Tray. | 28 cases (112 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1062-2023 | LOCAL PACK. Sterile Procedural Tray. | 8 cases (200 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1063-2023 | Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC | 12 cases (60 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1064-2023 | UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray | 20 cases (120 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1065-2023 | FEMORAL ARTERY PACK-LF. Sterile Procedural Tray | 15 cases (30 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1066-2023 | Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO | 314 cases (719 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1067-2023 | Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART CDS PART A n. GLENNON OPEN HEART CDS o.… | 12,964 cases (23,379 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1068-2023 | Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j. VEIN PACK k. VENOUS ACCESS PACK-LF l. VENOUS… | 622 cases (1,619 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1069-2023 | Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST | 200 cases (858 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1070-2023 | Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL | 174 cases (750 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1071-2023 | Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY | 86 cases (152 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1072-2023 | Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l. MINOR ENT SINUS PACK-LF m. MAJOR EAR… | 9,079 cases (27,563 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1073-2023 | Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF | 237 cases (1,242 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1074-2023 | Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MAJOR PROCEDURE-LF i. HYPOSPADIUS CDS j. LAPAROSCOPY-GENERAL k. LAP CHOLE CDS l. GENERAL LAPAROSCOPY… | 42,593 cases (117,470 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1075-2023 | Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY | 48 cases (96 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1076-2023 | Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO | 20 cases (72 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1077-2023 | Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR CDS-LF k. PLASTIC BREAST CDS-LF l.… | 6,420 cases (15,009 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1078-2023 | Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWEST k. SINGLE BASIN PACK-LF l. AGHM MINOR SINGLE… | 2.542 cases (6,739 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1079-2023 | Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROCEDURE n. MAJOR VASCULAR CDS o. PEDI… | 62,930 cases (215,456 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1080-2023 | Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK | 26 cases (104 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1081-2023 | Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK | 36 cases (116 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1082-2023 | Sterile Procedural Trays, labeled as the following: IM NAIL | 40 cases (40 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1083-2023 | Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN | 100 cases (156 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1084-2023 | Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF | 50 cases (200 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1085-2023 | Sterile Procedural Trays, labeled as the following: LS MS PACK | 159 cases (159 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1086-2023 | Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK | 5 cases (5 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1087-2023 | Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK | 36 cases (216 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1088-2023 | Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF l. U H S NEURO PACK SC m. NEURO PACK-CELEBRATION n.… | 6,782 cases (15,253 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1089-2023 | Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II | 194 cases (508 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1090-2023 | Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY | 109 cases (316 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1091-2023 | Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH GEN/GYN ROBOTIC CDS k. LAVH CDS-LF l. GYN… | 8,064 cases (12,425 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1092-2023 | Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i. C-SECTION CDS-LF j. C-SECTION CDS k. C-SECTION CDS l. C-SECTION m. C-SECTION CDS n. C-SECTION PACK-LF o.… | 11,886 cases (27,144 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1093-2023 | Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD… | 1,258 cases (2,154 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1094-2023 | Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k. PK, ROBOTICS-ACCESSORY l. OBS PACK m. LAPAROSCOPY/D&C… | 1,212 cases (2,101 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1095-2023 | Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLOGY PACK l. OCULOPLASTIC PACK m. BLEPH PACK n. EYE… | 260 cases (1,200 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1096-2023 | Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TOTAL KNEE CDS-LF n. TOTAL SHOULDER CDS-LF… | 101,102 cases (227,538 units) | Class II | Ongoing | 15 Feb 2023 |
| Z-1097-2023 | Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF j. ARTHROSCOPY PACK-LF k. ARTHROSCOPY BASIN PACK-LF… | 1,419 cases (4,349 units) | Class II | Ongoing | 15 Feb 2023 |
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 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 38Median of the firm: 2
- Events of the firm on the register
- 120
Other events of the firm
Official channels
- FDA enforcement report Z-1060-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 91386. https://recallregister.com/fda/ii/91386/. 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:
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- What quantity of product is in FDA event 91386?
- The event has 38 product records. The first record gives this quantity:
48 cases (96 units)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.