Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
FDA Recall Z-1224-2013 · Posted 2013-05-03
Advertisement
Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeGCX
Date Initiated2013-03-27
Date Terminated2013-09-24
Product Quantity147,921 - all sizes
Reason for Recall
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.
Firm Action
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.
Root Cause
Error in labeling
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement