Remel SWIN 2017 Database Recalled for Potential Out-of-Range Microbial Results
Remel Inc. is recalling 250 units of the SWIN 2017 database (Model YSW4000) due to the potential for out-of-range microbial results.
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: The recall is classified as FDA Class II, and the hazard involves potential for out-of-range microbial results, which poses a risk of harm without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Remel Inc. is recalling 250 units of the SWIN 2017 database, Model YSW4000. The recall is issued because the product has the potential to produce out-of-range microbial results.
The source text does not specify the distribution pattern, specific dates, or geographic locations where the product was sold. It also does not report any specific illnesses or injuries associated with the use of this database.
Consumers and healthcare facilities should stop using the affected SWIN 2017 database units and contact Remel Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- SWIN 2017 database, Model YSW4000
- Manufacturer
- Remel Inc.
- Hazard
- Affected units
- 250
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 (1)
- ...
Distribution
Distribution scope not specified by the agency.
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