45cm Laparoscopic Instruments Sterilization tray. Manufactured by: Stryker Endoscopy, 5900 Optical Court,San Jose, CA 95
FDA device recall Z-2612-2011 · posted 2011-06-22 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- During testing and review, Stryker Endoscopy discovered that the sterilization parameters for the 132 degree C gravity steam sterilization cycle in the IFU may not consistently sterilize all instruments in the 45cm Laparoscopic Instruments Tray.
- Action taken
- Stryker Endoscopy sent a "URGENT: DEVICE CORRECTION" letter dated June 8, 2011 to affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to discard all old Instructions for Use sheets for their 45cm Laparoscopic Tray and download the new IFU from the URL link:http://stryker.com/45cm tray. Additionally, customers were instructed to complete and return an attached "acknowledgement of receipt" form and fax to 408-754-8378 or scan and e-mail to trays@stryker.com. Questions can be answered by calling 1-800-624-4422 or by e-mail at trays@stryker.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KCT
- Quantity affected
- 603
- Distribution
- Worldwide Distribution--USA (nationwide) and countries of Brazil, Canada, Chili, Germany , Korea, Mexico, Philippines, Poland, Portugal, Singapore, Sweden, Switzerland, and Taiwan.
- Date initiated
- 2011-06-08
- Date posted
- 2011-06-22
- Date terminated
- 2011-10-25
- Location
- San Jose, CA
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