Home / Recalls / Medical Devices
Coloplast Manufacturing US, LLC recalls Ureteral dilator, REF RBD014
Recalled April 10, 2024 · FDA recall Z-1463-2024 · Coloplast Manufacturing US
Hazard
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility. · FDA Class II
Units
710 units
Sold at
US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
Description
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
Product
Ureteral dilator, REF RBD014
Manufacturer(s)
Coloplast Manufacturing US, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →