MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L
This recall is currently active, issued December 5, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- October 9, 2024
- Posted
- December 5, 2024
- Recall Number
- Z-0631-2025
- Quantity
- 70 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Distribution
US Nationwide distribution.
Lot / Code Info
1) REF DYNJ44673G, UDI/DI 10195327127473 (each) 40195327127474 (case), Lot Numbers: 23GDB181; 2) REF DYNJ49672L , UDI/DI 10195327127794 (each) 40195327127795 (case), Lot Numbers: 22GDB352, 22FDC210
Root Cause
Under Investigation by firm
Action Taken
Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.