—#116762

Product

Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.

FDA product code: GCX — Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K954726
Affected lot / code info: Manufacturer Part Number: 250-070-403

Why it was recalled

The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.

Root cause (FDA determination)

Error in labeling

Action the firm took

Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

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.

Timeline

Recall initiated: 2013-03-27
Posted by FDA: 2013-05-03
Terminated: 2013-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116762. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.