FDAFDA · Food and drugs·Recall number Z-0970-2020
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Published February 12, 2020 · Recall initiated: January 4, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Inc.
- Distributor
- 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.
- Lot
- 8494465 8513227 8537103 8537104 8552050 8552051 8567256 8576963 8632766 8639366 8659206 8683459 8754089 NS8513228
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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