Recall Z-2201-2016 ยท DQX Wire, Guide, Catheter
Arrow International Inc
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
| Date | Jul 12, 2016 (initiated Jun 2, 2016) |
| Status | Terminated |
| Reason | Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits. |
| Root cause | Labeling mix-ups |
| Action | Arrow International mailed an Urgent Medical Device Recall Notification letter and acknowledgement form dated June 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected product within your control to identify if the shipping corrugate label correctly identifies the products inside the shipping carton. Products with an incorrect label on the shipping carton can be |
| Quantity | 50 units in total |
| Distribution | US distribution in the states of TN and KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K810675 | ARROW RADIAL ARTERY CATHETERIZATION SET Arrow Intl., Inc., Mar 27, 1981 |