Recall Z-0199-2023 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Access Vascular, Inc.
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
| Date | Nov 8, 2022 (initiated Feb 24, 2021) |
| Status | Terminated |
| 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. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 79 kits |
| Distribution | Domestic distribution to NC, RI, NJ, and IL. No foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193015 | HydroPICC (PICC-142) Access Vascular, Inc., Feb 20, 2020 |