Recall Z-1713-2014 ยท DYB Introducer, Catheter
Arrow International Inc
Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
| Date | Jun 4, 2014 (initiated Apr 14, 2014) |
| Status | Terminated |
| Reason | Arrow is recalling the Arrow Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage. |
| Root cause | Process control |
| Action | Teleflex/Arrow International sent an Urgent Medical Device Recall Notification letter dated April 17, 2014, to distributors and end users. 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 and to complete the enclosed Recall Acknowledgement Form and fax it to 1-800-343-2935 to return product. Customers would be contacted by a customer service representative for a Return Goods Authorization (RGA) Numbers and would be provided instructions for the return of th |
| Quantity | 15424 |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780532 | PERCUTANEOUS SHEATH INTRODUCER KIT Arrow Intl., Inc., Apr 21, 1978 |