Recall Z-0001-2024 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
ARROW INTERNATIONAL Inc.
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
| Date | Oct 5, 2023 (initiated Aug 10, 2023) |
| Status | Open, Classified |
| Reason | This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. |
| Root cause | Under Investigation by firm |
| Action | Teleflex/Arrow International issue an URGENT MEDICAL DEVICE RECALL notice on 08/10/2023 by FedEx 2nd day mail. The letter explained the problem, risk to patient, and requested the following actions: Medical facilities: Immediately cease use and distribution of affected product and quarantine for return. Distributors: Immediately cease use and distribution of affected product and quarantine for return. Provide a copy of this recall notice to all customers who have received impacted product. Request they complete the Acknowledgement Form and return it to you. Firm is requesting return |
| Quantity | 1173 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Feb 4, 2016 |