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FDAFDA · Food and drugs·Recall number Z-0626-2025

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

Published December 11, 2024 · Recall initiated: October 9, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Distributor
US Nationwide distribution.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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