Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.
This recall has been terminated (originally issued March 23, 2006).
- Company
- Cook Urological, Inc.
- Recall Initiated
- March 1, 2006
- Posted
- March 23, 2006
- Terminated
- July 1, 2008
- Recall Number
- Z-0674-06
- Quantity
- 1300
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide, Australia, Canada, Caracas, Chile, Colombia, Hong Kong, India, Ireland, Israel, Malaysia, Mexico, New Zealand, Paraguay, Taiwan and Venezuela.
Lot / Code Info
All units.
Root Cause
Other
Action Taken
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.