FDA Enforcement
Class II
Ongoing
Ureteral dilator, REF RBD014
Recall: Z-1463-2024
·
Reported April 10, 2024
Enforcement
- Recall Number
- Z-1463-2024
- Event ID
- 94218
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Coloplast Manufacturing US, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 10, 2024
- Initiation Date
- March 11, 2024
- Classification Date
- April 2, 2024
- Address
- 1601 W River Rd, Minneapolis, MN, 55411-3431, United States
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.
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
Distribution
US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
Quantity
710 units