The Recall Desk
HighFDA (Devices)·Z-1428-2024·Announced 2024-04-10

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.

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: 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
Hazard
  • sterility-breach
  • manufacturing-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 (3)

  • UDI/DI 00653160352054 (case)
  • 10653160352051 (each)
  • Lot Numbers: 2023071390

Distribution

Distributed nationwide across the United States.

Related recalls

Same category