MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C
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-0626-2025
- 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 DYNJ00281O, UDI/DI 10193489962963 (each) 40193489962964 (case), Lot Numbers: 22KMA417, 22FMD671; 2) REF DYNJ0101291F, UDI/DI 10195327286644 (each) 40195327286645 (case), Lot Numbers: 23FDA396, 23HDA759, 23EDB388, 23LDB909; 3) REF DYNJ0488546K, UDI/DI 10195327505097 (each) 40195327505098 (case), Lot Numbers: 23IBP983; 4) REF DYNJ84762, UDI/DI 10195327413088 (each) 40195327413089 (case), Lot Numbers: 23IMA327, 23IMA727; 5) REF DYNJ906907C, UDI/DI 10195327376819 (each) 40195327376810 (case), Lot Numbers: 23DBM940, 23FBG165, 23IBQ680
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.