FDAFDA · Food and drugs·Recall number Z-3034-2024
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
Published September 18, 2024 · Recall initiated: April 8, 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
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.
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
- Worldwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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