Cook Urological, Inc. Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.
Brand
Cook Urological, Inc.
Lot Codes / Batch Numbers
All units.
Products Sold
All units.
Cook Urological, Inc. is recalling Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540. due to Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026