Device product
Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Z-1227-2013
Product summary
- Event
- Event 64682
- Status
- Terminated
- Classification
- Class II
- Quantity
- 147,921 - all sizes
- Official record key
device-enforcement:Z-1227-2013
Official wording
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 information: Manufacturer Part Number: 250-070-472
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.
Derived failure modes
-
Unknown
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.