FDA-Device2024-04-10Class II
Ureteral dilator, REF RBD014
Coloplast Manufacturing US, LLC
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.
Sold states
US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
Affected count
710 units
Manufactured in
1601 W River Rd, Minneapolis, MN, United States
Products
Ureteral dilator, REF RBD014
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1463-2024Don't want to check this manually?
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