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U.S. Department of Health and Human Services

Class 2 Device Recall StrykeFlow 2 suction/irrigator

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  Class 2 Device Recall StrykeFlow 2 suction/irrigator see related information
Date Initiated by Firm November 17, 2017
Create Date March 02, 2018
Recall Status1 Terminated 3 on January 29, 2024
Recall Number Z-0835-2018
Recall Event ID 78668
510(K)Number K934094  K954726  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
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
Code Information 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
Recalling Firm/
Manufacturer		 Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
Manufacturer Reason
for Recall		 Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
FDA Determined
Cause 2		 Under Investigation by 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 endocustomersupport@stryker.com to arrange for product return.
Quantity in Commerce 60,753 units total
Distribution Distributed domestically to . Distributed internationally to Australia and Mexico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = STRYKER CORP.
510(K)s with Product Code = GCJ and Original Applicant = Stryker Endoscopy
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