The Recall Desk
HighFDA (Devices)·Z-3039-2024·Announced 2024-09-18

Medline Medical Convenience Kits Recalled for Syringe Defects

Medline Convenience kits containing defective plastic syringes are being recalled worldwide due to leaks, breakage, and quality issues that may pose patient health risks.

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 medical device (Class II) with identified quality defects (leaks, breakage) that pose a risk of harm to patients. No injuries or illnesses have been reported. This matches the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling Convenience kits labeled as OR CLEAN UP KIT (Pack Number DYK1002355X3, Lot Number 21JFA080) and CLEANING & CUTTING (Pack Number DYNJ84657, Lot Number 23GBD229). The kits contain plastic syringes affected by an FDA Safety Alert dated March 19, 2024.

The affected syringes have been identified with leaks, breakage, and other quality issues. The FDA states these defects may pose a risk to patient health.

The kits have been distributed worldwide. Consumers and healthcare providers with these kits should not use them.

The recalled product

Product
Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • device-defect
  • 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 (4)

  • DYK1002355X3
  • Lot Number 21JFA080
  • DYNJ84657
  • Lot Number 23GBD229

Distribution

Distribution scope not specified by the agency.