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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable StrykeFlow Tips

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  Class 2 Device Recall Disposable StrykeFlow Tips see related information
Date Initiated by Firm June 20, 2014
Date Posted July 19, 2014
Recall Status1 Terminated 3 on October 15, 2014
Recall Number Z-2080-2014
Recall Event ID 68624
510(K)Number K042457  
Product Classification System, irrigation, urological - Product Code LJH
Product Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
Code Information P/N 0250070505; Lot numbers: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2.
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Michael Hilldoerfer
408-754-2664
Manufacturer Reason
for Recall		 Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.
FDA Determined
Cause 2		 Other
Action Stryker sent an Urgent Device Removal letter via certified mail on June 20, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any unused product, inform individuals within their organization who need to aware of the device removal. Customers with questions were instructed to call 1-800-624-4422. For questions regarding this recall call 408-754-2664.
Quantity in Commerce 496 boxes (6 tips per box)
Distribution Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Canada, France, Greece, Netherlands, United kingdom and South Korea.
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 = LJH and Original Applicant = W.O.M. WORLD OF MEDICINE AG
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