HydroPICC Catheter Kits Recalled for Expiration Date Mislabeling
240 units of HydroPICC 4Fr Single Lumen Catheter Maximal Barrier Kits are being recalled because the catheter's actual expiration date is shorter than the date printed on the outer package.
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: Risk-of-harm medical device recall with no reported injuries. Expiration date discrepancy on a sterile catheter creates potential for use beyond the safe window, posing infection risk. FDA Class II classification and mislabeling of critical safety information (expiration dating) justifies High severity.
Plain-English summary
Access Vascular, Inc. is recalling HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit (Model Number 80001004) due to a labeling discrepancy. The catheter packaged with specific lots has an actual expiration date that is shorter than the expiration date printed on the outer kit package.
240 units were distributed in Florida, Tennessee, and Texas. Healthcare providers and patients who received this product should verify the expiration date printed directly on the catheter itself, as the outer package may not reflect the actual safe-use window.
The recalled product
- Product
- HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
- Manufacturer
- Access Vascular, Inc
- Affected units
- 240
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: 00862559000487
- Lot Number: 11423949
Distribution
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