Recall Z-2274-2010 ยท KGZ Accessories, Catheter
Arrow International Inc
Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801
| Date | Aug 25, 2010 (initiated Jun 7, 2010) |
| Status | Terminated |
| Reason | Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed. |
| Root cause | Process change control |
| Action | June 7, 2010 Notification letter to customer instructed them to return the product to Arrow. Arrow will destroy the returned product. |
| Quantity | 3000 kits |
| Distribution | All affected product was distributed to one foreign consignee: Arrow Japan Ltd. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K781846 | ADAPTER, CATHETER SHEATH Arrow Intl., Inc., Dec 12, 1978 |