Recall Z-0199-2023
Access Vascular, Inc. · initiated February 24, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Codes / lots: UDI-DI: 00862559000418 Catheter Kit Lots/Expiration Dates 09112001 Exp 9/24/2021 10212001 Exp 10/21/21 10282001 Exp 11/18/21 Scalpel Lots/Expiration Dates R18-08-010 Exp Feb-21 R19-01-009 Exp Jun-21 R20-01-010 Exp Aug-22 StatLock Lots/Expiration Dates R18-09-008 Exp 5/28/2021
Reason for recall
Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.
FDA-determined cause: Process design
Action taken
Beginning February 24, 2021, the firm notified its affected consignees via Email. Customers were informed that if product had already been used, then no action was required, because all components were still within their expiration date at the time, and no patient safety risk was identified. If product had not been used, customers were asked to refrain from using product until a replacement Scalpel and Statlock were provided.
Details
- Recall number
- Z-0199-2023
- Initiated
- February 24, 2021
- Posted by FDA
- November 8, 2022
- Terminated
- May 30, 2024
- Product code
- LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Quantity
- 79 kits
- Distribution
- Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.
- Recalling firm
- Access Vascular, Inc., Billerica, MA