Ureteral dilator, REF RBD014
- Company
- Coloplast Manufacturing Us, Llc
- Recall Initiated
- March 11, 2024
- Posted
- April 2, 2024
- Recall Number
- Z-1463-2024
- Quantity
- 710 units
- Firm Location
- Minneapolis, MN
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.
Distribution
US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
Lot / Code Info
UDI-DI: 03600040300503, Lot codes: 6885096, 6928493, 7036982, 7092593, 7148682, 7187751, 7275918, 7326750, 7362229, 7405815, 7424892, 7440816, 7459583, 7528743, 7575957, 7742150, 7806993, 7825256, 7874646, 7948615, 8050730, 8122897, 8174950, 8210399, 8313229, 8350283, 8359041, 8442175, 8519426, 8619976, 8700201, 8864944, 8946228, 8946264, 9122793, 9122794, 9168554, 9226390, 9246177, 9360599
Root Cause
Under Investigation by firm
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.