Recall Z-1290-2022 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
ARROW INTERNATIONAL Inc.
Arrow Three-Lumen CVC
| Date | Jun 27, 2022 (initiated May 5, 2022) |
| Status | Terminated |
| Reason | Gravity flow rates on the affected product lidstock are incorrect. |
| Root cause | Error in labeling |
| Action | A recall notification was issued to the consignee on 05/05/2022 via FedEx 2-day mail. The letter instructs the consignee to check the inventory, place a copy of the letter with all affected product and return the response form if the consignee is a medical facility. If the consignee is a distributor, the letter instructs the consignee to provide the notice to their customers, check the inventory, return the completed response form. An updated notification was sent on about 08/09/2022, via FedEx. The updated notification provided an additional description of the label error. Product scope r |
| Quantity | 10,301 units |
| Distribution | US Nationwide distribution in the states of Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970864 | ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS Arrow Intl., Inc., Oct 17, 1997 |