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 Recall Z-0835-2018 · Posted None
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Recalling FirmStryker Corporation
Recall StatusTerminated
Product CodeGCJ
Date Initiated2017-11-17
Date Terminated2024-01-29
Product Quantity60,753 units total
Reason for Recall
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Firm Action
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 [email protected] to arrange for product return.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed domestically to . Distributed internationally to Australia and Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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