FDA recall Z-1463-2024

Product

Ureteral dilator, REF RBD014

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

Key facts

Status

Ongoing

Initiation date

2024-03-11

Report date

2024-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1463-2024