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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

Product Description Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Recall Number Z-1229-2013
Classification Class II
Code Info Manufacturer Part Number: 250-070-482
Product Distributed Qty 147,921 - all sizes
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.

Event Detail

Event Id 64682
Product Type Devices
Status Ongoing
Recalling Firm Stryker Endoscopy
City San Jose
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-27
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.