| Class 2 Device Recall Stryker Irrigator Reusable Tips | |
Date Initiated by Firm | March 27, 2013 |
Date Posted | May 03, 2013 |
Recall Status1 |
Terminated 3 on September 24, 2013 |
Recall Number | Z-1233-2013 |
Recall Event ID |
64682 |
510(K)Number | K954726 |
Product Classification |
Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
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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 CA 95138-1400
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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 121-123C , instead of the correct 132-133C. |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = GCX
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