Access Vascular, Inc. Recall 90981
Description: Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Access Vascular, Inc. Recall 90981 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0199-2023 |
| Event ID | 90981 |
| Event Description | Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter |
| Product Type | Devices |
| Distribution | Domestic distribution to NC, RI, NJ, and IL. No foreign distribution. |
| Quantity | 79 kits |
| Recall Reason | 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. |
| Device Classification | 20221116 |
| Device 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 |
| Center Classification Date | 20221107 |
| Recall Initiation Date | 20210224 |
| Recalling Firm | Access Vascular, Inc. |
| Initial Notification | Letter |
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