Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
FDA device recall Z-0199-2023 · posted 2022-11-08 · Terminated
Recall details
- Recalling firm
- Access Vascular, Inc.
- 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.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 79 kits
- Distribution
- Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.
- Date initiated
- 2021-02-24
- Date posted
- 2022-11-08
- Date terminated
- 2024-05-30
- Location
- Billerica, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HydroPICC (PICC-142) (K193015) | Access Vascular, Inc. | 2020-02-20 |