Reported Apr 10, 2024 · Ongoing
Ureteral dilator, REF RBD014
Coloplast Manufacturing US, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Coloplast Manufacturing US, LLC · 1601 W River Rd · Minneapolis, MN · 55411-3431
Is this the product you have?
- Ureteral dilator, REF RBD014
- Lot codes and dates
- UDI-DI03600040300503
- Lot codes
6885096692849370369827092593714868271877517275918732675073622297405815742489274408167459583752874375759577742150780699378252567874646794861580507308122897817495082103998313229835028383590418442175851942686199768700201886494489462288946264912279391227949168554922639092461779360599
- Amount recalled
- 710 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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