Z-3056-2024 Class II Ongoing
FDA device recall Z-3056-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Apr 8, 2024 and is designated Class II. 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… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2024
- Initiation Date
- Apr 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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
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
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3056-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026