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Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; ...

FDA Device Recall #Z-3056-2024 — Class II — April 8, 2024

Recall Summary

Recall Number Z-3056-2024
Classification Class II — Moderate risk
Date Initiated April 8, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices

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.

Lot / 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

Other Recalls from MEDLINE INDUSTRIES, LP - Northfield

Recall # Classification Product Date
Z-2567-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2566-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2479-2025 Class II Medline Kits containing BD SureStep Foley Tray ... Jul 23, 2025
Z-2460-2025 Class I Medline ReNewal Reprocessed St. Jude Medical Re... Jul 14, 2025
Z-2452-2025 Class II The Medline General Surgery Tray is customized ... Jul 8, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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