Recall Z-0102-2023 ยท PND Midline Catheter
ARROW INTERNATIONAL Inc.
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
| Date | Oct 19, 2022 (initiated Sep 14, 2022) |
| Status | Terminated |
| Reason | Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1). |
| Root cause | Under Investigation by firm |
| Action | The firm sent an URGENT MEDICAL DEVICE NOTFICATION to its sole consignee on 09/15/2022, by FedEx 2-day mail. The letter explained the reason for recall and requested the following: "Please adhere to the following actions: 1. Check your inventory for products in scope of this advisory notice. 2. If you do not have affected product, mark the applicable checkbox on the Acknowledgement Form (Appendix 2) and return the form to Teleflex Customer Service using the contact information below. 3. If you have affected product, mark the applicable checkbox on the Acknowledgement Form (Appendix 2), return |
| Quantity | 18 devices |
| Distribution | US Nationwide distribution in the state of Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Aug 24, 2016 |