The Recall Desk
HighFDA (Devices)·Z-3035-2024·Announced 2024-09-18

Medline Convenience Kits with Defective Plastic Syringes Recalled

Medline is recalling convenience kits containing plastic syringes with quality issues including leaks and breakage that may affect patient safety. The 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: This is an FDA Class II recall involving defective syringes with leaks and breakage that may pose a risk of harm to patients. No illnesses or injuries have been reported in the source material. Per the rubric, risk-of-harm products where injury has not yet been reported are scored at 3 (High).

Plain-English summary

Medline Industries, LP is recalling Admit Kit Pillow Box convenience kits (Pack Number DYKA1389, Lot Number 21IMA285) containing plastic syringes affected by an FDA Safety Alert issued on March 19, 2024.

The recalled kits contain syringes with identified quality issues including leaks and breakage. These defects may pose a risk to patient health and proper medication administration.

The convenience kits have been distributed worldwide. Consumers and healthcare facilities should stop using these kits and contact Medline Industries for further instructions regarding the recall.

The recalled product

Product
Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • syringe-defect
  • leak
  • 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 (2)

  • DYKA1389
  • Lot Number 21IMA285

Distribution

Distribution scope not specified by the agency.