Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.
FDA Recall Z-0674-06 · Posted 2006-03-23
Recalling FirmCook Urological, Inc.
Recall StatusTerminated
Product CodeFAD
Date Initiated2006-03-01
Date Terminated2008-07-01
Product Quantity1300
Reason for Recall
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.
Firm Action
Consignees were notified via letter dated 3/1/06 that included one copy of the instructions. Consignees were asked to inform the firm of how many additional copies were needed for stocks on hand and instructed to make copies as needed until additional supplies are received.
Root Cause
Other
Distribution Pattern
Nationwide, Australia, Canada, Caracas, Chile, Colombia, Hong Kong, India, Ireland, Israel, Malaysia, Mexico, New Zealand, Paraguay, Taiwan and Venezuela.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.