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U.S. Department of Health and Human Services

Class 2 Device Recall Replacement HEPA filter

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  Class 2 Device Recall Replacement HEPA filter see related information
Date Initiated by Firm April 22, 2016
Date Posted June 01, 2016
Recall Status1 Terminated 3 on December 16, 2016
Recall Number Z-1878-2016
Recall Event ID 74004
Product Classification Device, pasteurization, hot water - Product Code LDS
Product Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
Code Information Filter Serial Numbers: Filter SN: 2522893, 2522897, 2522898, 2522899, 2522900, 2522903, 2522914, 2522915, 2522916, 2522917, 2522918, 2522919, 2522920, 2522921, 2522922, 2522923, 2522924, 2522925, 2522926, 2522930, and 2522931.
Recalling Firm/
Natus Medical Incorporated
5900 1st Ave S
Seattle WA 98108-3248
For Additional Information Contact Seattle Technical Service
866-940-7143 Ext. 1
Manufacturer Reason
for Recall
The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Natus sent an " URGENT RECALL NOTIFICATION/ FIELD SAFETY NOTICE" Olympic Sterile Driers Model 43 & 44, Replacement HEPA Filter Contamination letter (dated April 22, 2016) was sent to all affected customers on May 2, 2016. for the first set of customers and then sent on May 12, 2016, for the second set of customers, who purchased 57 replacement filters. Customers are advised "do not install any replacement HEPA filter" if the serial number is one of the 21 shown as affected serial numbers on the letter. The URGENT RECALL NOTIFICATION/ FIELD SAFETY NOTICE Olympic Sterile Driers Model 43 & 44, Potential HEPA Filter Contamination (dated May, 2016 and released on May 12, 2016,) was sent to customers on May 16, 2016, who purchased 11 sterile driers with the installed filters. Customers are advised "do not use the Sterile drier" if it contains a HEPA filter that is identified with one of 21 affected serial numbers. Customers are advised not to install any defective replacement HEPA filters or do not use sterile drier if it currently contains defective HEPA filter. Please discontinue use of the Sterile Drier immediately if it contains defective HEPA filter as heat may cause the uncured adhesive to drip into the chamber. Customers contact Natus to obtain the RMA number and return unused filters and Natus will provide a replacement filter. Please contact Natus at Seattle_Technical_Service@natus.com or call 866-940-7143 (option 1, Olympic products) for next steps regarding a contaminated Sterile Drier.
Quantity in Commerce 21 filters
Distribution distributed in the US including AZ, CA, FL, IL, KS, MA, MD, MN, NC, NH, NY, OH, OK, PA, VA, WA, WA DC,and WI and in Canada and Singapore.
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.