Stryker Endoscopy: Medical Device Recall in 2013 - (Recall #: Z-1232-2013)
See the recall detail below. You can also see other recalls from the same firm in 2013.
Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Class II
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.
Manufacturer Part Number: 250-070-487
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.
Voluntary: Firm initiated