The Recall Desk
HighFDA (Devices)·Z-3056-2024·Announced 2024-09-18

Medical Convenience Kits Recalled for Syringe Leaks and Breakage

Medline Industries is recalling multiple medical convenience kits containing plastic syringes that may leak or break, posing a risk to patient health. The affected kits have been distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with potential safety issues (syringe leaks and breakage) in clinical use, but no reported illnesses or injuries. Classified as risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling multiple medical convenience kits and suturing sets containing plastic syringes. The recall affects products distributed worldwide, including multiple pack numbers and associated lot numbers.

Quality issues have been identified in the plastic syringes used in these convenience kits, including leaks, breakage, and other defects that may pose a risk to patient health. The recall was initiated in connection with an FDA Safety Alert dated March 19, 2024.

Affected lot numbers and pack numbers are detailed in the official FDA recall notice. Healthcare facilities and individuals should verify whether their supplies match any of the affected product codes.

The recalled product

Product
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 SE
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • syringe-leakage
  • syringe-breakage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 59112
  • Lot Number 21VBA069
  • DYNDL1984
  • Lot Number 22IBK601
  • Lot Number 22LBA112
  • Lot Number 23CBJ757
  • Lot Number 23FBI531
  • DYNJ68267A
  • Lot Number 23GBW001
  • Lot Number 23IBD069
  • MNS15015
  • Lot Number 23DLA584
  • Lot Number 23GLB127
  • Lot Number 23ILA127
  • Lot Number 23ILA978
  • Lot Number 23JLA433
  • Lot Number 23KLA928
  • MNS15015H
  • SUT21770
  • Lot Number 23DBI036

Distribution

Distribution scope not specified by the agency.