Recall Z-1463-2024— Coloplast Manufacturing US, LLC

Name: FDA recall Z-1463-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-11

Class II · Ongoing

Class II FDA medical device recall by Coloplast Manufacturing US, LLC, initiated 2024-03-11. It names one FDA 510(k) clearance: K170531. Product: Ureteral dilator, REF RBD014. Reason: 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..

Recalling firm: Coloplast Manufacturing US, LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-03-11
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K170531 — Ureteral Dilators and Percutaneous Nephrostomy DilatorsColoplast Corp.·cleared 2017-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.