Recall Z-2741-2016 ยท DQX Wire, Guide, Catheter
Arrow International Inc
Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
| Date | Sep 7, 2016 (initiated Aug 8, 2016) |
| Status | Terminated |
| Reason | Shipping carton labeling error. |
| Root cause | Process control |
| Action | Teleflex sent an Urgent Medical Device Recall Notification letter dated August 23, 2016, via FED-Ex 2 Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine all affected products. Instructions for the products return were provided in the firm's recall notification letter. Customers were asked to complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. Customers with questions were instructed to ca |
| Quantity | 690 kits |
| Distribution | Nationwide Distribution to OH, IN, TN, NC, 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 |