Z-3034-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3 PTE0000204 , Pack Number DYNJ65728A ; 3) 30ML KIT, Pack Number DYNJ82155A ; 4) DISSECTION, Pack Number DYNJ85191; 5) FLAP HARVEST PACK , Pack Number DYNJ58575C ; 6) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212H ; 7) FLAP HARVEST PACK, Pack Number DYNJ58575C
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Distribution Pattern
Worldwide distribution.
Code Information
DYND30212, Lot Number 20CBV412 ; DYND30212H , Lot Number 20CBV412 ; DYNJ58575C, Lot Number 22FMF260; DYNJ58575C, Lot Number 22EMI154; DYNJ58575C , Lot Number 22JMF580 ; DYNJ65728A , Lot Number 21IBJ821 ; DYNJ65728A , Lot Number 21IBV204 ; DYNJ65728A , Lot Number 21JBE157 ; DYNJ82155A , Lot Number 23CBD960 ; DYNJ82155A , Lot Number 23CBH024 ; DYNJ82155A , Lot Number 23DBL430 ; DYNJ82155A , Lot Number 23EBI493 ; DYNJ82155A , Lot Number 23FBO135 ; DYNJ82155A , Lot Number 23FBO795 ; DYNJ82155A , Lot Number 23GBJ181 ; DYNJ82155A , Lot Number 23HBJ559 ; DYNJ82155A , Lot Number 23IBJ041 ; DYNJ82155A , Lot Number 23IBJ042 ; DYNJ85191, Lot Number 23JBP679