The Recall Desk
HighFDA (Devices)·Z-3031-2024·Announced 2024-09-18

Medical convenience kits with plastic syringes recalled for leaks and breakage

Medline is recalling medical convenience kits with plastic syringes that may leak or break. The FDA issued a safety alert due to quality defects that could harm patients.

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 syringes with identified leaks and breakage that may harm patients. No illnesses or injuries have been reported, placing this in the High category for risk-of-harm products without documented injury.

Plain-English summary

Medline Industries is recalling medical convenience kits containing plastic syringes due to identified quality defects. The affected products include filter kits (pack 2008) and anesthesia circuit kits (pack DYNJAA10295A), distributed worldwide.

The syringes in these kits are subject to an FDA Safety Alert issued March 19, 2024. They may have leaks, breakage, and other quality issues that could pose risks to patient health.

Consumers and healthcare facilities should not use the affected kits. Contact Medline Industries or your healthcare provider for guidance. The affected lot numbers are 23ABN325 (filter kits), 22EBI496, and 22CBX850 (anesthesia circuit kits).

The recalled product

Product
Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Number DYNJAA10295A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • syringe-leak
  • 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 (5)

  • 2008
  • Lot Number 23ABN325
  • DYNJAA10295A
  • Lot Number 22EBI496
  • Lot Number 22CBX850

Distribution

Distribution scope not specified by the agency.