The Recall Desk
HighFDA (Devices)·Z-2981-2024·Announced 2024-09-18

Medline Medical Convenience Kits With Defective Syringes Recalled Worldwide

Medline recalled medical convenience kits containing plastic syringes with leaks, breakage, and quality defects. The affected syringes may pose a risk to patient health.

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: Medline kits contain syringes with identified defects that may pose health risks. Per the severity rubric, this qualifies as a risk-of-harm medical device with Class II designation, corresponding to High severity.

Plain-English summary

Medline Industries, LP is recalling medical convenience kits due to defective plastic syringes. The recalled products are the Tracheotomy Tray (Pack Number DYNDA1894) and Ultrasound Guided PIV Kit (Pack Number MNS9580). The syringes are affected by an FDA Safety Alert issued on March 19, 2024, and have been identified with leaks, breakage, and other quality issues that may pose a risk to patient health.

These convenience kits have been distributed worldwide. The affected lot numbers are: DYNDA1894 Lot Number 2019080890, DYNDA1894 Lot Number 2019082190, and MNS9580 Lot Number 2019080890.

Users of these products should immediately discontinue use of the affected lots.

The recalled product

Product
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • syringe-leak
  • syringe-breakage
  • equipment-defect

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)

  • DYNDA1894
  • Lot Number 2019080890
  • Lot Number 2019082190
  • MNS9580

Distribution

Distribution scope not specified by the agency.