The Recall Desk
HighFDA (Devices)·Z-2985-2024·Announced 2024-09-18

Medline Convenience Kits Recalled Due to Plastic Syringe Quality Issues

Medline is recalling specific convenience kits because they contain plastic syringes with leaks, breakage, or 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: The recall is classified as FDA Class II and involves a risk to patient health due to syringe defects, but the source text does not report any specific injuries or hospitalizations, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling specific convenience kits, including the Hood Pack, ICU Respiratory Bronch Pack, and OSC Bronch Pack. These kits contain plastic syringes that are affected by an FDA Safety Alert issued on March 19, 2024.

The recall is being conducted because leaks, breakage, and other quality issues have been identified in the syringes. These defects may pose a risk to patient health. The affected products were distributed worldwide.

Healthcare facilities and consumers should stop using the affected kits and contact Medline Industries for further instructions on how to return or dispose of the products.

The recalled product

Product
Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPIRATORY BRONCH PACK ; 3) DYNJ80281A , Pack Number OSC BRONCH PACK

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)

  • DYNJ59573A
  • Lot Number 23IBP764
  • Lot Number 23JBM050
  • Lot Number 23KBM610
  • Lot Number 24ABC779
  • DYNJ39451D
  • Lot Number 22BDB647
  • Lot Number 22CDA099
  • Lot Number 22LDA195
  • Lot Number 23DDB501
  • Lot Number 23DDB666
  • Lot Number 23EDA821
  • DYNJ80281A
  • Lot Number 23ADA194
  • Lot Number 23DDA881
  • Lot Number 23HDA513
  • Lot Number 23JDC172
  • Lot Number 23LDB860
  • Lot Number 24ADC258
  • Lot Number 24CDA973

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 81 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 81 products in this recall →