—#160091

Product

StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K934094, K954726
Affected lot / code info: a. Model 0250070500, Product Code GCJ, UDI 07613327061390, Lot No. 17275FG2, 17276FG2, 17277FG2, 17278FG2, 17279FG2, 17280FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17290FG2, 17291FG2, 17292FG2, 17293FG2, 17294FG2, 17297FG2, 17299FG2, 17301FG2); 0250070505, 0250070520; b. Model 0250070505, Product Code GCX, UDI 07613327061406, Lot No. 17294FG2; c. Model 0250070520, Product Code GCX, UDI 07613327061369, Lot No. 17282FG2, 17283FG2, 17286FG2, 17289FG2, 17290FG2, 17292FG2, 17293FG2, 17294FG2, 17296FG2, 17297FG2, 17298FG2, 17299FG2, 17300FG2, 17301FG2, 17302FG2

Why it was recalled

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On about 11/17/2017 letters were sent by certified mail with tracking information to all domestic accounts and International Stryker sites were notified by email. Instructions include to inform individuals who need to be aware of the device recall, examine all stock areas and/or operating room storage for affected product quarantine and discontinue use of the recalled devices, complete the acknowledgement form, and if affected product is found contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return.

Recalling firm

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

Distribution

Distribution pattern: Distributed domestically to . Distributed internationally to Australia and Mexico.

Timeline

Recall initiated: 2017-11-17
Terminated: 2024-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160091. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.