Coloplast Ureteral Dilators Recalled Due to Sterile Packaging Issue
Coloplast Manufacturing is recalling 710 ureteral dilators due to a possible breach in sterile packaging detected during facility testing. The devices are distributed across multiple US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device with a potential packaging breach that could lead to contamination and infection. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported, fitting the High (3) severity category.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling 710 ureteral dilators (REF RBD014) due to a possible sterility issue. A breach in the sterile packaging was detected during facility testing.
The recalled devices were distributed to healthcare facilities in Georgia, Mississippi, Tennessee, Minnesota, Arizona, Maryland, Louisiana, Kansas, and Washington. Affected lot codes include: 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.
A breach in sterile packaging creates a potential risk of contamination. No illnesses or injuries have been reported to date.
Healthcare providers who have received these devices should stop using the affected units and contact Coloplast Manufacturing for guidance on disposal and replacement options.
The recalled product
- Product
- Ureteral dilator, REF RBD014
- Manufacturer
- Coloplast Manufacturing US, LLC
- Affected units
- 710
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 03600040300503
- Lot codes: 6885096
- 6928493
- 7036982
- 7092593
- 7148682
- 7187751
- 7275918
- 7326750
- 7362229
- 7405815
- 7424892
- 7440816
- 7459583
- 7528743
- 7575957
- 7742150
- 7806993
- 7825256
- 7874646
Distribution
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