Summary
The FDA issued a Class II for Ureteral dilator, REF RBD014 by Coloplast Manufacturing US, LLC. 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 .
Details
Source
Device Recall
External ID
Z-1463-2024
Action Date
2024-04-10
Status
Ongoing
Category
device
Product Description
Ureteral dilator, REF RBD014
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
Quantity Affected: 710 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-11
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Coloplast Manufacturing US, LLC has 21 FDA actions in our database, including 21 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Coloplast Manufacturing US, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Coloplast Manufacturing US, LLC have FDA actions?
Coloplast Manufacturing US, LLC has 21 FDA actions in our database, including 21 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1463-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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