FDA Recall
Open, Classified
Ureteral dilator, REF RBD014
Recall: Z-1463-2024
·
Initiated March 11, 2024
Recall
- Recall Number
- Z-1463-2024
- Event Number
- 94218
- Firm
- Coloplast Manufacturing US, LLC
- FEI Number
- 2125050
- Product Code
- EZN
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 11, 2024
- Posted
- April 2, 2024
- Address
- 1601 W River Rd, Minneapolis, MN, 55411-3431
Description
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.
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.
Distribution
US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
Quantity
710 units