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
Hazard
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
What You Should Do
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.
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Products
- Brand
- Stryker Corporation
- UPC
- 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
Units Affected
60,753 units total