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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 Recall
Stryker Irrigator Reusable Tips
see related information
Date Posted May 03, 2013
Recall Status1 Terminated on September 24, 2013
Recall Number Z-1233-2013
Recall Event ID 64682
Premarket Notification
510(K) Number
K954726 
Product Classification Apparatus, Suction, Operating-Room, Wall Vacuum Powered - Product Code GCX
Product Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code Information Manufacturer Part Number: 250-070-488
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose, California 95138-1400
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Michael Hilldoerfer
408-754-2664
Manufacturer Reason
for Recall
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action Stryker 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 Commerce 147,921 - all sizes
Distribution Worldwide 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 Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCX and Original Applicant = Stryker Endoscopy
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