Recall Z-2080-2014 ยท LJH System, Irrigation, Urological
Stryker Endoscopy
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
| Date | Jul 19, 2014 (initiated Jun 20, 2014) |
| Status | Terminated |
| Reason | Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product. |
| Root cause | Other |
| Action | Stryker sent an Urgent Device Removal letter via certified mail on June 20, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any unused product, inform individuals within their organization who need to aware of the device removal. Customers with questions were instructed to call 1-800-624-4422. For questions regarding this recall call 408-754-2664. |
| Quantity | 496 boxes (6 tips per box) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Canada, France, Greece, Netherlands, United kingdom and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042457 | URO PRO W.O.M. World of Medicine AG, Oct 25, 2004 |