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Recall Observatory FDA recall evidence

Device product

Ureteral dilator, REF RBD014

Z-1463-2024

March 11, 2024

Class II

Product summary

Firm
Coloplast Manufacturing US, LLC
Event
Event 94218
Status
Ongoing
Classification
Class II
Quantity
710 units
Official record key
device-enforcement:Z-1463-2024

Official wording

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 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

Distribution pattern: US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.