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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
Part of a larger recall action
This product is one of 7 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.
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