Recall Z-2591-2023 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
ARROW INTERNATIONAL Inc.
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
| Date | Sep 15, 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 | 177 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121941 | ARROW PICC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.), Sep 7, 2012 |