Recall Z-0279-06 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Stryker Endoscopy
StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 95138
| Date | Dec 14, 2005 (initiated Nov 18, 2005) |
| Status | Terminated |
| Reason | Devices for which sterility may be compromised as evidenced by a crack in the package. |
| Root cause | Other |
| Action | On 11/18/05, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. |
| Quantity | 48405 boxes, 6 units per box |
| Distribution | The product was distributed nationally to 1321 consignees and internationally to 18 consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042454 | STRYKER CASSETTE PUMP Stryker Endoscopy, Dec 9, 2004 |