Z-1463-2024 Class II Ongoing
FDA device recall Z-1463-2024 was initiated by Coloplast Manufacturing US, LLC on March 11, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 710 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2024
- Initiation Date
- March 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 710 units
Product Description
Ureteral dilator, REF RBD014
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 Pattern
US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
Code Information
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