—#128339

Product

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.

FDA product code: LJH — System, Irrigation, Urological
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K042457
Affected lot / code info: P/N 0250070505; Lot numbers: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Canada, France, Greece, Netherlands, United kingdom and South Korea.

Timeline

Recall initiated: 2014-06-20
Posted by FDA: 2014-07-19
Terminated: 2014-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128339. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.