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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Irrigator Reusable Tips

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 Class 2 Device Recall Stryker Irrigator Reusable Tipssee related information
Date Initiated by FirmMarch 27, 2013
Date PostedMay 03, 2013
Recall Status1 Terminated 3 on September 24, 2013
Recall NumberZ-1223-2013
Recall Event ID 64682
510(K)NumberK954726 
Product Classification Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
ProductStryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code Information Manufacturer Part Number: 250-070-409
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information ContactMichael Hilldoerfer
408-754-2664
Manufacturer Reason
for Recall		The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.
FDA Determined
Cause 2		Error in labeling
ActionStryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in Commerce147,921 - all sizes
DistributionWorldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GCX
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