The Recall Desk
HighFDA (Devices)·Z-3043-2024·Announced 2024-09-18

Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage

Medline Convenience kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may pose risks to patient health. The recall affects kits with Pack Number DYNDH1453 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: FDA Class II classification applies. The source identifies concrete quality defects (leaks, breakage) in a medical device that may pose patient risk, but no illnesses or injuries have been reported, making this a high-risk situation where harm has not yet occurred.

Plain-English summary

Medline Industries is recalling Convenience kits labeled as HSG TRAY (Pack Number DYNDH1453) that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024.

The recalled syringes have leaks, breakage, and other quality issues identified that may pose a risk to patient health. Affected lot numbers include 20EBA949, 21ABR125, 22FMA793, 22HMD391, and 22HMD549.

The kits have been distributed worldwide. Persons using these products should contact Medline Industries for additional guidance on affected units.

The recalled product

Product
Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Medical Kits / Syringes
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 (6)

  • DYNDH1453
  • Lot Number 20EBA949
  • Lot Number 21ABR125
  • Lot Number 22FMA793
  • Lot Number 22HMD391
  • Lot Number 22HMD549

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category