Class II
Medical Device Recall: Ureteral dilator, REF RBD014
Coloplast Manufacturing US, LLC · March 11, 2024
Reason for Recall
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.
Distribution
US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
States Affected
AZ, GA, KS, LA, MD, MN, MS, TN, WA
Quantity Affected
710 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1463-2024
Status: ongoing
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