—#170630

Product

Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844

FDA product code: KOE — Dilator, Urethral
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K892855
Affected lot / code info: 8494465 8513227 8537103 8537104 8552050 8552051 8567256 8576963 8632766 8639366 8659206 8683459 8754089 NS8513228

Why it was recalled

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Root cause (FDA determination)

Process control

Action the firm took

On January 4, 2019, the firm distributed Urgent Medical Device Recall letters to customers via courier mail. Customers were informed that affected lots may contain a wire guide that was incorrectly loaded into the wire guide holder.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.

Timeline

Recall initiated: 2019-01-04
Terminated: 2020-05-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170630. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.