MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST CHARLES PORT, REFDYNJ909591
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-0624-2025
- Quantity
- 1271 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 DYNJ39185D, UDI/DI 10195327157166 (each) 40195327157167 (case), Lot Numbers: 22GBA088, 22FBS934, 22HBA086; 2) REF DYNJ44997J, UDI/DI 1019532738093 (each) 40195327380930 (case), Lot Numbers: 23GBU050, 23KBI422, 23JBL004, 23IBB532, 23LBK392, 24BBA287, 24CBM430; 3) REF DYNJ58409C, UDI/DI 10193489957242 (each) 40193489957243 (case), Lot Numbers: 22GBT985, 22LBD309, 23JBP407; 4) REF DYNJ66252A, UDI/DI 10193489887853 (each) 40193489887854 (case), Lot Numbers: 22OBL262; 5) REF DYNJ909591, UDI/DI 10195327413613 (each) 40195327413614 (case), Lot Numbers: DYNJ909591
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.