Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irr
FDA device recall Z-2080-2014 · posted 2014-07-19 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJH
- Quantity affected
- 496 boxes (6 tips per box)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Canada, France, Greece, Netherlands, United kingdom and South Korea.
- Date initiated
- 2014-06-20
- Date posted
- 2014-07-19
- Date terminated
- 2014-10-15
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| URO PRO (K042457) | W.O.M. World of Medicine AG | 2004-10-25 |