The Recall Desk
HighFDA (Devices)·Z-2986-2024·Announced 2024-09-18

Medline medical convenience kits recalled due to syringe quality defects

Medline is recalling multiple medical convenience kits worldwide that contain plastic syringes with defects that may leak or break, posing a risk to patient safety.

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: This is a Class II FDA recall of medical devices (plastic syringes) identified as risk-of-harm products due to potential leakage and breakage. No illnesses or injuries have been reported in the source, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling multiple medical convenience kits distributed worldwide that contain plastic syringes affected by quality issues. The recalled products include the Sterile Lidocaine Syringe Pack, Pediatric EP Pack, Cardiac Minor-LF Pack, Cardiac Minor Surgicount Pack, and Pediatric EP Pack MHS, each with specific affected lot numbers identified.

The plastic syringes in these kits may leak, break, or experience other quality issues that could pose a risk to patient health. This recall is related to an FDA Safety Alert issued on March 19, 2024.

Healthcare facilities and practitioners who have received these kits should stop using the affected lot numbers and contact Medline Industries for guidance on return, replacement, or other appropriate actions.

The recalled product

Product
Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ; 3) CARDIAC MINOR-LF, Pack Number DYNJ51939; 4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573; 5) PEDIATRIC EP PACKMH
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical/Medical Kits
Hazard
  • leakage
  • 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)

  • DYNDM1076A . Lot Number 19CBP748
  • DYNDM1076A . Lot Number 19DBH317
  • DYNDM1076A . Lot Number 19FBT944
  • DYNJ45158A . Lot Number 21KBK059
  • DYNJ45158A . Lot Number 21LBB289
  • DYNJ45158A . Lot Number 19ABZ159
  • DYNJ45158A . Lot Number 22DBS953
  • DYNJ45158A . Lot Number 22GBC899
  • DYNJ45158A . Lot Number 22GBE801
  • DYNJ45158A . Lot Number 19FBG969
  • DYNJ45158A . Lot Number 19FBM779
  • DYNJ45158A . Lot Number 19GBS210
  • DYNJ45158A . Lot Number 19HBS882
  • DYNJ45158A . Lot Number 19IBN282
  • DYNJ45158A . Lot Number 19JBB002
  • DYNJ45158A . Lot Number 23ABR333
  • DYNJ45158A . Lot Number 23CBK931
  • DYNJ45158A . Lot Number 23HBJ279
  • DYNJ45158A . Lot Number 23IBF733
  • DYNJ45158A . Lot Number 20HBR669

Distribution

Distribution scope not specified by the agency.

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