FDA recall Z-0978-2020

Product

Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703 G53706 G53711 G53723 G53724 G53725 G53726

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2019-01-04

Report date

2020-02-12

Termination date

2020-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0978-2020