Critical Care Decontamination System recall: Contamination
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for…
Why was Critical Care Decontamination System recalled?
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.
- Product
- Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for…
- Recalling firm
- Battelle Memorial Institute
- Quantity
- 898
- Distribution
- US Nationwide distribution including in the states of CT, MA, RI.
- Recall date
- November 4, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)