The Recall Desk
HighFDA (Devices)·Z-2754-2024·Announced 2024-09-04

Medline Procedural Kits with Defective Syringes Recalled Worldwide

Medline procedural kits with defective plastic syringes are recalled due to risks of leaks and breakage. The affected syringes were flagged in an FDA safety alert and may compromise patient safety during medical procedures.

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 involves medical syringes with potential for leaks and breakage during procedures, representing a risk of patient harm. No illnesses, injuries, or deaths are reported in the source material. The hazard is unconfirmed; therefore, this fits the rubric criterion 'risk-of-harm products where injury has not yet been reported'.

Plain-English summary

Medline Industries is recalling Arthrograph Tray procedural kits (Pack Number MNS12670A, Lot 2022112990) worldwide due to defective plastic syringes. The syringes have been identified with quality issues including leaks and breakage, as referenced in an FDA Safety Alert from March 19, 2024. These defects may pose a risk to patient health during medical procedures.

The affected kits have been distributed worldwide. Healthcare facilities and patients who have received these kits should discontinue use and contact Medline Industries for instructions on replacement or return.

Consumers and healthcare providers should verify whether they have received affected lots (2022112990) and take appropriate action to prevent use in patient care settings.

The recalled product

Product
Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • syringe-leak
  • syringe-breakage
  • equipment-failure

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 (2)

  • MNS12670A
  • Lot Number 2022112990

Distribution

Distribution scope not specified by the agency.