The Recall Desk
HighFDA (Devices)·Z-3041-2024·Announced 2024-09-18

Medline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage

Medline Industries is recalling medical convenience kits containing plastic syringes with leaks, breakage, and other quality issues that 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: This is an FDA Class II recall of medical syringes with identified defects (leaks, breakage, quality issues) that may pose risk to patient health. No illnesses or injuries have been reported, qualifying this as high severity for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling medical convenience kits that contain plastic syringes. The kits are distributed worldwide and include 68 different product types, each identified by specific pack numbers and lot numbers.

The plastic syringes in these kits have been identified as defective following an FDA Safety Alert issued on March 19, 2024. Issues include leaks, breakage, and other quality defects that may pose a risk to patient health.

Healthcare facilities and medical providers who have received these kits should stop using the affected lot numbers and contact Medline Industries for guidance. Consumers and patients with questions about affected products should refer to the official FDA recall notice.

The recalled product

Product
Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY, Pack
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • syringe-leak
  • syringe-breakage
  • defective-device

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 (20)

  • DYNDA2063
  • Lot Number 2021111250
  • DYNDA2080
  • Lot Number 2019052290
  • DYNDA2495
  • Lot Number 2021040550
  • DYNDA2497
  • Lot Number 2022042650
  • DYNDH1113
  • Lot Number 2020022450
  • DYNDH1134
  • Lot Number 2021022250
  • DYNDH1137C
  • Lot Number 2021081990
  • DYNDH1257
  • Lot Number 2019120650
  • Lot Number 2020060550
  • Lot Number 2021041550
  • DYNDH1270
  • Lot Number 2019040490

Distribution

Distribution scope not specified by the agency.