Salyer Prn Biomedical Recalls Century Console Base Units
Salyer Prn Biomedical is recalling 9 Century Console Base units because the addition of a UPS Battery Backup did not comply with FDA premarket notification regulations.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates a regulatory compliance issue regarding premarket notification rather than a direct safety hazard or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Salyer Prn Biomedical is recalling 9 units of the Century Console Base, Model #043625051b. This device is intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
The recall was initiated because the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with FDA premarket notification regulations. The affected units were distributed in the states of Massachusetts, California, and Wisconsin.
The specific serial numbers for the recalled units are CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144. Users should contact Salyer Prn Biomedical for further instructions regarding the recall.
The recalled product
- Product
- Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
- Manufacturer
- Salyer Prn Biomedical
- Affected units
- 9
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 (9)
- Serial Numbers: CCB40120
- CCB40121
- CCB40122
- CCB40123
- CCB40124
- CCB40139
- CCB40140
- CCB40143
- and CCB40144.
Distribution
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