FDAFDA · Food and drugs·Recall number Z-3036-2024
Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408VH; 3) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492A ; 4) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492AH; 5) KIT ANGIO CSTM-PROVIDENCE , Pack Number SAMP0545
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
- DYNJ0621408V, Lot Number 23ILB053; DYNJ0621408VH, Lot Number 23ILB053; DYNJ0864492A , Lot Number 21KMH585 ; DYNJ0864492AH, Lot Number 21KMH585 ; SAMP0545 , Lot Number 22GME387 ; SAMP0545 , Lot Number 22GME980
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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