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
This recall has been terminated (originally issued November 17, 2017).
- Company
- Stryker Corporation
- Recall Initiated
- November 17, 2017
- Terminated
- January 29, 2024
- Recall Number
- Z-0835-2018
- Quantity
- 60,753 units total
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Distribution
Distributed domestically to . Distributed internationally to Australia and Mexico.
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
Root Cause
Under Investigation by firm
Action Taken
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.