Recall Z-0468-2014 ยท DYB Introducer, Catheter
Arrow International Inc
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
| Date | Dec 9, 2013 (initiated Oct 9, 2013) |
| Status | Terminated |
| Reason | There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient. |
| Root cause | Process control |
| Action | Arrow International sent an Urgent Medical Device Recall Notification letter dated October 14, 2013, to all affected customers. 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 any affected product,to return product complete the enclosed Recall Acknowledgement Form and fax to 1-800-343-2935, ATTN: Customer Service. Customers were asked to completed the Recall Acknowledgement Form even if they have none of the affected product. Customers with questions were instructed to conta |
| Quantity | 294430 |
| Distribution | Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Brazil, Canada, China, Ireland, New Zealand, Singapore, and Thailand. |
| FDA record | Open on fda.gov |