Recall Z-0114-2024 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Access Vascular, Inc
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
| Date | Oct 13, 2023 (initiated Aug 31, 2023) |
| Status | Open, Classified |
| Reason | Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date. |
| Root cause | Error in labeling |
| Action | An Urgent Medical Device Correction notification letter dated 8/25/23 was sent to customers. 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. All catheters to date have been used with adult patients. - Product that has not been used: The kit does not have the current IFU. Please refer to the Rev C. IFU provided with this letter. Also, the Patient Information Card, part number LS-067, includes a barcode link to the c |
| Quantity | 58 total |
| Distribution | US Nationwide distribution in the states of IL, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213550 | HydroPICC 5F Dual Lumen Catheter Access Vascular, Inc., May 4, 2022 |