Battelle Recalls Critical Care Decontamination System N95 Respirators
Battelle Memorial Institute is recalling 898 N95 respirators decontaminated by its Critical Care Decontamination System. The recall is due to a failure to maintain required condensation levels during the decontamination cycle.
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 involves a medical device used to prevent exposure to pathogenic biological airborne particulates. The failure to maintain condensation levels represents a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Battelle Memorial Institute is recalling 898 Critical Care Decontamination System (CCDS) compatible N95 respirators. These respirators were distributed nationwide, including in Connecticut, Massachusetts, and Rhode Island, between July 1, 2020, and August 12, 2020. The products were used by healthcare personnel to decontaminate N95 respirators for multiple-user reuse during the Coronavirus Disease 2019 (COVID-19) pandemic.
The recall was initiated because masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle. This deviation from the intended process may affect the efficacy of the decontamination. The source text does not report any illnesses or injuries associated with the use of these products.
Healthcare personnel who used these specific respirators should contact Battelle Memorial Institute for further instructions. Consumers should not use the recalled respirators until further notice.
The recalled product
- Product
- Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are…
- Manufacturer
- Battelle Memorial Institute
- Affected units
- 898
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 (2)
- All decontaminated compatible N95 respirators distributed from Providence
- RI between 07/01/2020 and 08/12/2020.
Distribution
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