The Recall Desk
HighFDA (Devices)·Z-1447-2024·Announced 2024-04-10

Centurion PICC Line Securement Kit Recalled for Weak Seal

MEDLINE is recalling the Centurion PICC Line Securement Kit because its seal may be weak, potentially allowing sterility breach. Users may not be able to detect the weakness.

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 Class II FDA recall involves a medical device used for central venous access. Although no illnesses or injuries have been reported, the weak seal creates a risk of sterility breach, which could lead to serious infection. The potential for harm in a critical medical device justifies a High severity rating.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling 300 units of the Centurion PICC LINE SECUREMENT KIT (Product Code IVS565) from lot number 2023070790.

The product may have a weak seal that could allow a breach of sterility of the kit contents if the seal fails. The weakness may not be detectable by all users.

The affected product was distributed worldwide, including the United States, Panama, and Canada.

The recalled product

Product
Centurion PICC LINE SECUREMENT KIT, Product Code IVS565
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — PICC Line Securement
Hazard
  • weak-seal
  • sterility-breach

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)

  • UDI/DI 10653160175971 (case) 00653160175974 (each)
  • Lot Numbers: 2023070790

Distribution

Distributed nationwide across the United States.

Related recalls

Same category