Recall Z-0088-04 ยท KZH Introducer, Syringe Needle
Arrow International Inc
10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set
| Date | Nov 1, 2003 (initiated Oct 22, 2003) |
| Status | Terminated |
| Reason | package lid identifies the contents incorrectly |
| Root cause | Other |
| Action | The recalling firm notified the consignees via telephone on 10/22/03 regarding the problem and the need to return the product. |
| Quantity | 80 units |
| Distribution | The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka |
| 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 |