Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
- Company
- Access Vascular, Inc
- Recall Initiated
- February 24, 2021
- Posted
- November 8, 2022
- Terminated
- May 30, 2024
- Recall Number
- Z-0199-2023
- Quantity
- 79 kits
- Firm Location
- Billerica, MA
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.
Distribution
Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.
Lot / Code Info
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
Root 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.