The Recall Desk
HighFDA (Devices)·Z-3018-2024·Announced 2024-09-18

Medline Convenience Kits Recalled Due to Plastic Syringe Quality Issues

Medline is recalling convenience kits containing plastic syringes affected by an FDA Safety Alert. The syringes have 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 the source text states that quality issues 'may pose a risk to patient health' without reporting specific injuries or illnesses, which aligns 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 that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The affected products include various basin packs and surgical kits, such as the GER ARTH BASIN PK RFID-LF and PEDIATRIC MAJOR BASIN PACK-LF, among many others listed in the recall notice.

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

Healthcare facilities and consumers should check their inventory for the specific pack numbers and lot numbers listed in the official recall notice. If you have these products, stop using them and contact Medline Industries for instructions on how to return or dispose of the affected kits.

The recalled product

Product
Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2) PEDIATRIC MAJOR BASIN PACK-LF , Pack Number DYNJ0154061C ; 3) EYE BASIN PACK-LF , Pack Number DYNJ0259872M ; 4) EYE BASIN PACK-LF , Pack Number DYNJ0259872MH; 5) BASIN DBL 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)

  • DYNJ0100999K
  • Lot Number 23CDA712
  • Lot Number 23FDB897
  • Lot Number 23KDA691
  • Lot Number 23LDB403
  • DYNJ0154061C
  • Lot Number 23KBT382
  • Lot Number 23LBT241
  • Lot Number 23EMD583
  • Lot Number 23FME877
  • Lot Number 23GMB699
  • Lot Number 23GMI468
  • DYNJ0259872M
  • Lot Number 23FMG803
  • Lot Number 23HMB007
  • DYNJ0259872MH
  • DYNJ0287720N
  • Lot Number 23EMG655
  • Lot Number 23FMF756
  • Lot Number 23JMI005

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 →