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.
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 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
- Affected units
- 300
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.
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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