Recall Z-1064-2016 ยท DYB Introducer, Catheter
Arrow International Inc
Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque with Integral Hemostasis Valve/Side Port, 3-way Stopcock and Tissue Dilator 1: . . . . . . . . . . .
| Date | Jan 12, 2016 |
| Status | Terminated |
| Reason | Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur. |
| Root cause | Packaging process control |
| Action | Arrow International sent an Urgent Medical Device Recall Notification letter dated January 13, 2016, 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. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recall@telefex.com. A customer service representative will contact them with a Return Goods Authorization (RGA) Number and will provide inst |
| Quantity | 56,521 units |
| Distribution | Nationwide Distribution including AL AR AZ CA CO CT DE FL GA IA ID IL IN KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC TN TX UT VA VT WA WI WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924607 | ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET Arrow Intl., Inc., Apr 22, 1993 |