Scalpel and StatLock in HydroPICC kits expire before label indicates
Access Vascular recalls 79 HydroPICC catheter kits because included scalpel and StatLock components have earlier expiration dates than stated on the 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: FDA Class II recall with expiration dating discrepancy on sterile medical device components. No illnesses or injuries reported. This is a risk-of-harm product where expired sterile components could compromise sterility during central catheter insertion, meeting the High severity criterion for products where injury has not yet been reported.
Plain-English summary
Access Vascular, Inc. is recalling 79 kits of HydroPICC Catheter Kit (PICC-142), a Peripherally Inserted Central Catheter system. The scalpel and StatLock components included in specific lots have expiration dates that are shorter than what is printed on the outer kit package.
Healthcare facilities may be unaware of this discrepancy and could use the components based on the package expiration date, which differs from the actual component expiration dates. The actual expiration dates for affected components are earlier than the dates labeled on the kit packaging.
The recalled kits were distributed to healthcare facilities in North Carolina, Rhode Island, New Jersey, and Illinois. Specific lot numbers and actual expiration dates for the affected catheter kits, scalpels, and StatLock components are available from the manufacturer.
Facilities with affected kits should verify the actual expiration dates of the scalpel and StatLock components against the corrected dates provided by Access Vascular. Any components that have already expired should not be used. For the complete list of affected lots and their correct expiration dates, contact Access Vascular or consult the FDA recall notice.
The recalled product
- Product
- Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
- Manufacturer
- Access Vascular, Inc.
- Affected units
- 79
Distribution
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