FDAMarch 11, 2024device
Ureteral dilator, REF RBD014
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
coloplast manufacturingcoloplast
UPCs
03600040300503
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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