Home / Recalls / MEDLINE INDUSTRIES, LP - Northfield / Z-0158-2025

Z-0158-2025 Class II Ongoing

Recalled by MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

Recall Details

Product Type
Devices
Report Date
October 30, 2024
Initiation Date
September 4, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,426 units

Product Description

Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF DYNJ63165B; g) BIOPSY TRAY FOAKS, REF DYNJ63575A; h) CUSTOM SOFT TISSUE PACK, REF DYNJ66347A; i) KWIK PACK, REF DYNJ67926B; j) ESI TRAY, REF DYNJ68261B; k) LARGE BIOPSY PACK NTX, REF DYNJ68393A; l) LOOP KIT, REF DYNJ84129

Reason for Recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Code Information

a) REF DYNJ17534L, UDI/DI 40195327258253 (each), 10195327258252 (case), Lot Numbers: 23KBF936; b) REF DYNJ43076A, UDI/DI 40195327080625 (each), 10195327080624 (case), Lot Numbers: 23LBI584; c) REF DYNJ49404C, UDI/DI 40195327395453 (each), 10195327395452 (case), Lot Numbers: 23LBP833; d) REF DYNJ52666C, UDI/DI 40193489452144 (each), 10193489452143 (case), Lot Numbers: 23LBN740; e) REF DYNJ61130B, UDI/DI 40195327054589 (each), 10195327054588 (case), Lot Numbers: 23LBP401; f) REF DYNJ63165B, UDI/DI 40193489461580 (each), 10193489461589 (case), Lot Numbers: 23KBD517; g) REF DYNJ63575A, UDI/DI 40193489429337 (each), 10193489429336 (case), Lot Numbers: 23LBR787; h) REF DYNJ66347A, UDI/DI 40193489884716 (each), 10193489884715 (case), Lot Numbers: 24ABA444; i) REF DYNJ67926B, UDI/DI 40195327519514 (each), 10195327519513 (case), Lot Numbers: 23LBL347; j) REF DYNJ68261B, UDI/DI 40195327513369 (each), 10195327513368 (case), Lot Numbers: 24ABA492; k) REF DYNJ68393A, UDI/DI 40193489939997 (each), 10193489939996 (case), Lot Numbers: 23LBL431; l) REF DYNJ84129, UDI/DI 40195327334544 (each), 10195327334543 (case), Lot Numbers: 23KBB926

Other recalls by MEDLINE INDUSTRIES, LP - Northfield

  • Z-2566-2025 Class I — Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Nu (July 25, 2025)
  • Z-2567-2025 Class I — Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Ki (July 25, 2025)
  • Z-2479-2025 Class II — Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: C (July 23, 2025)
  • Z-2460-2025 Class I — Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Ele (July 14, 2025)
  • Z-2452-2025 Class II — The Medline General Surgery Tray is customized to meet requirements of the hospi (July 8, 2025)
  • D-0604-2025 Class II — Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 (July 7, 2025)
  • D-0601-2025 Class II — CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 3 (July 7, 2025)
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  • D-0600-2025 Class II — Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single (July 7, 2025)
  • D-0602-2025 Class II — ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart (July 7, 2025)