Recall Z-1005-2018 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent
| Date | Nov 27, 2017 |
| Status | Terminated |
| Reason | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. |
| Root cause | Error in labeling |
| Action | On November 29, 2017 an Urgent Medical Device Correction notice was issued to customers stating the following: Our records indicate that you have received products that are subject to this action. We are now notifying our distributors to take the following actions: 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected products within your control to identify whether they have the sticker with the lot number, expiration date, and UDI information. Products missing this sticker should be returned to Arrow In |
| Quantity | 23,904 in total |
| Distribution | US in the states of OH, FL, SC, TX, KY, NJ, MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER Arrow International, Inc., Aug 30, 2007 |