FDA Enforcement
Class II
Terminated
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Recall: Z-1223-2013
·
Reported May 15, 2013
Enforcement
- Recall Number
- Z-1223-2013
- Event ID
- 64682
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Endoscopy
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 15, 2013
- Initiation Date
- March 27, 2013
- Classification Date
- May 3, 2013
- Termination Date
- September 24, 2013
- Address
- 5900 Optical Ct, N/A, San Jose, CA, 95138-1400, United States
Description
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason
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.
Code Info
Manufacturer Part Number: 250-070-409
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.
Quantity
147,921 - all sizes