Class 2 Device Recall Battelle Critical Care Decontamination System (CCDS)

• Date Initiated by Firm: August 13, 2020
• Create Date: October 29, 2020
• Recall Status: Terminated on February 03, 2021
• Recall Number: Z-0309-2021
• Recall Event ID: 86347
• Product Classification: Decontamination systems for N95 respirators - Product Code QKY
• 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 insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.
• Code Information: All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.
• Recalling Firm/ Manufacturer: Battelle Memorial Institute; 505 King Ave; Columbus OH 43201-2696
• For Additional Information Contact: CCDS Customer Service; 614-424-4373
• Manufacturer Reason for Recall: Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
• FDA Determined Cause: Under Investigation by firm
• Action: Customers were notified via email on 8/13/20: Dear CCDSTM Customer, Recently, we became aware that masks processed at the Providence, RI CCDSTM site were not maintained at levels of condensation during a portion of the decontamination cycle. The first phase (gassing phase) operated as intended. The next phase (dwell phase) had a gradual decline of condensation. The CCDSTM team has corrected this and has confirmed that the system is operating correctly. The normal CCDSTM decontamination cycles operate above the levels of regulatory guidelines. To ensure that our process decontaminated the masks effectively, our research team replicated this process cycle, including the deviated dwell phase, with a similar number of masks in the chamber. As expected, the results showed a 6-log reduction. Though this was a deviation to an internal operating procedure, out of caution, we are asking you to return your masks to the CCDSTM site to be reprocessed. We will send you replacement masks if you need them while your masks are being decontaminated. Battelle CCDSTM is committed to maintaining the highest standards for our customers. Please contact us with any questions. Sincerely, Battelle CCDSTM Team Call us at 614-424-4373 ccdscustomerservice@battelle.org
• Quantity in Commerce: 898
• Distribution: US Nationwide distribution including in the states of CT, MA, RI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.