The Recall Desk
HighFDA (Devices)·Z-2779-2024·Announced 2024-09-04

Centurion Procedure Packs With Defective Syringes Recalled Worldwide

Medline Industries is recalling Centurion procedure packs containing plastic syringes with identified leaks, breakage, and quality defects. The recall affects units 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: Quality defects have been identified in medical syringes (leaks, breakage) that may pose risk to patient health. This is a risk-of-harm product where no illnesses or injuries have been reported, meeting the rubric criterion for High severity.

Plain-English summary

Medline Industries, LP is recalling Centurion procedure packs containing plastic Caina syringes. The affected packs are labeled as Arthrogram Trays (Pack Number MNS11965A), Circumcision Trays (Pack Number CIT6720), and Circumcision Trays (Pack Number CIT6720A). These products have been distributed worldwide.

The syringes in these procedure packs are subject to the FDA safety alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health during medical procedures.

The recalled product

Product
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CIRCUMCISION TRAY, Pack Number CIT6720; 3) CIRCUMCISION TRAY, Pack Number CIT6720A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • leak
  • breakage
  • quality-defect

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)

  • MNS11965A
  • Lot Number 2023040690
  • CIT6720
  • Lot Number 2022122390
  • CIT6720A
  • Lot Number 2023110890

Distribution

Distribution scope not specified by the agency.