Recall Z-0076-2015 ยท DQY Catheter, Percutaneous
Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit
| Date | Oct 16, 2014 (initiated Sep 18, 2014) |
| Status | Terminated |
| Reason | Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date. |
| Root cause | Labeling False and Misleading |
| Action | Arrow International sent an Medical Device Advisory Notifications letter dated September 18, 2014, sent to direct accounts to notify them about the product, problem, and actions to be taken. Arrow International, Inc. (Arrow) is notifying customers that the label on the outer corrugate for the above mentioned product code and lot number is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date. Arrow International, Inc. is committed t |
| Quantity | 65 |
| Distribution | US Distribution including the states of MD, NC , LA , IN , OH, KY, CA , PA , NY and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862056 | [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP Arrow Intl., Inc., Aug 25, 1986 |