Ureteral dilator, REF RBD014
FDA device recall Z-1463-2024 · posted 2024-04-02 · Open, Classified
Recall details
- Recalling firm
- Coloplast Manufacturing US, LLC
- 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.
- Action taken
- 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: urology@coloplast.com, Phone: 800-258-3476) for a refund for returned product.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- EZN
- Quantity affected
- 710 units
- Distribution
- US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
- Date initiated
- 2024-03-11
- Date posted
- 2024-04-02
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ureteral Dilators and Percutaneous Nephrostomy Dilators (K170531) | Coloplast Corp. | 2017-08-17 |