Medline Pediatric Magill Catheter Recalled for Weak Seal Risk
Medline is recalling its Centurion FCP Magill Catheter (7.5 in. pediatric) because the product may have a weak seal that could compromise sterility. The affected units were distributed in the US, Panama, and Canada.
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: This is a Class II medical device recall involving potential sterility compromise on a pediatric catheter. Although no illnesses or injuries have been reported and the hazard is theoretical, the risk-of-harm from a sterility breach on a pediatric device is significant.
Plain-English summary
Medline Industries is recalling the Centurion FCP MAGILL CATH 7.5 IN PED (Product Code 67575), a pediatric catheter distributed worldwide.
The product may have a weak seal that could breach the sterility of the contents if the seal fails. A weak seal may not be detectable by users, potentially allowing compromised sterile devices to be inadvertently used.
The recall affects 480 units with Lot Number 2023071390 that were distributed in the United States, Panama, and Canada.
Healthcare providers and individuals with this product should stop using affected units and contact Medline Industries for return or replacement instructions.
The recalled product
- Product
- Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Catheter
- Affected units
- 480
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 (3)
- UDI/DI 00653160352054 (case)
- 10653160352051 (each)
- Lot Numbers: 2023071390
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 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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