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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 Tips see related information
Date Initiated by Firm March 27, 2013
Date Posted May 03, 2013
Recall Status1 Terminated 3 on September 24, 2013
Recall Number Z-1222-2013
Recall Event ID 64682
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, Metal Finish.

Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code Information Manufacturer Part Number: 250-070-408.
Recalling Firm/
Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Michael Hilldoerfer
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
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 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 = GCX and Original Applicant = Stryker Endoscopy