Ureteral dilator, REF RBD014
FDA Recall Z-1463-2024 · Posted 2024-04-02
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Recalling FirmColoplast Manufacturing US, LLC
Recall StatusOpen, Classified
Product CodeEZN
Date Initiated2024-03-11
Product Quantity710 units
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.
Firm Action
Coloplast issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice to its consignees on 03/11/2024 via USPS first class mail. The notice explained the issue and requested the consignee contact the firm ( Email: [email protected], Phone: 800-258-3476) for a refund for returned product.
Root Cause
Under Investigation by firm
Distribution Pattern
US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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