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All product recalls associated with Cook Urological, Inc..
Total Recalls
4
Past Year
0
Class I (Serious)
0
Most Recent
Jun 2007
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.
Lack of assurance of sterility, as the packages may not have been sealed.
Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58.