FDAFDA · Food and drugs·Recall number Z-3056-2024
Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number DYNDL1984; 3) CLOSING PACK, Pack Number DYNJ68267A ; 4) SUTURING KIT, Pack Number MNS15015 ; 5) SUTURING KIT, Pack Number MNS15015H; 6) SUTURING SET, Pack Number SUT21770 ; 7) SUTURE SET, Pack Number SUT21810 ; 8) SUTURING SET, Pack Number SUT21810H; 9) SUTURE TRAY , Pack Number SUT21830
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
- 59112, Lot Number 21VBA069 ; DYNDL1984, Lot Number 22IBK601 ; DYNDL1984, Lot Number 22LBA112 ; DYNDL1984, Lot Number 23CBJ757 ; DYNDL1984, Lot Number 23FBI531 ; DYNJ68267A , Lot Number 23GBW001 ; DYNJ68267A , Lot Number 23IBD069 ; MNS15015 , Lot Number 23DLA584 ; MNS15015 , Lot Number 23GLB127 ; MNS15015 , Lot Number 23ILA127 ; MNS15015 , Lot Number 23ILA978 ; MNS15015 , Lot Number 23JLA433 ; MNS15015 , Lot Number 23KLA928 ; MNS15015H, Lot Number 23DLA584 ; MNS15015H, Lot Number 23GLB127 ; MNS15015H, Lot Number 23ILA127 ; MNS15015H, Lot Number 23ILA978 ; MNS15015H, Lot Number 23JLA433 ; MNS15015H, Lot Number 23KLA928 ; SUT21770 , Lot Number 23DBI036 ; SUT21770 , Lot Number 23FBH231 ; SUT21770 , Lot Number 23GBM232 ; SUT21770 , Lot Number 23JBO236 ; SUT21770 , Lot Number 23JBP503 ; SUT21810 , Lot Number 23IBA704 ; SUT21810 , Lot Number 23JMF069 ; SUT21810 , Lot Number 23KME590 ; SUT21810H, Lot Number 23JMF069 ; SUT21810H, Lot Number 23KME590 ; SUT21810H, Lot Number 23IBA704 ; SUT21830 , Lot Number 23KBF032
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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