Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.

FDA device recall Z-0674-06 · posted 2006-03-23 · Terminated

Recall details

Recalling firm

Cook Urological, Inc.

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.

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.

Root cause

Other

Status

Terminated

Product code

FAD

Quantity affected

1300

Distribution

Nationwide, Australia, Canada, Caracas, Chile, Colombia, Hong Kong, India, Ireland, Israel, Malaysia, Mexico, New Zealand, Paraguay, Taiwan and Venezuela.

Date initiated

2006-03-01

Date posted

2006-03-23

Date terminated

2008-07-01

Location

Spencer, IN