Recall Z-1152-2018 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is i
| Date | Mar 21, 2018 (initiated Dec 21, 2017) |
| Status | Terminated |
| Reason | Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information. |
| Root cause | Process control |
| Action | Arrow International sent Notification letters to DISTRIBUTORS that include the following instructions: 1. Discontinue distribution and quarantine any affected products. 2. Inspect affected products to identify whether they have the lot number, expiration date, and UDI information. Products missing this information should be returned. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this recall to any customers who have received affected products. Customers should return mislabeled products. Products that are properly labeled should not be returned. 4. Any c |
| Quantity | 420 |
| Distribution | United States in the state of FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993691 | ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER Arrow Intl., Inc., Mar 8, 2000 |