CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report
Critical Care Decontamination System recalled
Battelle Memorial Institute is recalling Critical Care Decontamination System (CCDS) Compatible N95 respirators, distributed nationwide in the US. The recall was initiated on 13 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0309-2021
- FDA event ID
- 86347
- Recalling firm
- Battelle Memorial Institute, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Aug 2020
- FDA classified
- 29 Oct 2020
- Reported
- 4 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Particulate Matter
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Aug 2020 | Recall initiated by company | |
| 29 Oct 2020 | Classified by FDA | +77 days |
| 4 Nov 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Product as listed by the FDA
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 insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.
Where it was distributed
US Nationwide distribution including in the states of CT, MA, RI.
Questions about this recall
Why was it recalled?
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Which lots are affected?
All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.
Where was it sold?
US Nationwide distribution including in the states of CT, MA, RI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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