Recall Z-1605-2023 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Access Vascular, Inc
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
| Date | May 18, 2023 (initiated Mar 3, 2023) |
| Status | Open, Classified |
| Reason | The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package. |
| Root cause | Labeling mix-ups |
| Action | An "Urgent Medical Device Correction" notification letter was sent to customers on 3/3/23. Our records indicate that your facility has received kits from the affected lots. We are contacting you to provide information on action to take to ensure patient safety. - Product that has already been used: No action required. The catheter and all kit components are currently within their expiration date, so no patient safety risk has been identified. - Product that has not been used: The catheter and all kit components are currently, within their expiration date, so no immediate patient safety risk h |
| Quantity | 240 units |
| Distribution | US distribution to States of: FL, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193015 | HydroPICC (PICC-142) Access Vascular, Inc., Feb 20, 2020 |