Stryker Endoscopy recalls Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in cl

Recalled May 15, 2013 · FDA recall Z-1228-2013 · Stryker Endoscopy

Hazard

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. · FDA Class II

Units

147,921 - all sizes

Sold at

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.

Description

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.

Product

Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.

Manufacturer(s)

Stryker Endoscopy

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →