FDA Device recall Z-1878-2016
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44 by Natus Medical, citing 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 durin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1878-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-22 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Natus Medical |
| Distribution | AZ, CA, DC, FL, IL, KS, MA, MD, MN, NC, NH, NY, OH, OK, PA, VA, WA, WI |
Product
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
Reason
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.
Identifiers
| code_info | Filter Serial Numbers: Filter SN: 2522893, 2522897, 2522898, 2522899, 2522900, 2522903, 2522914, 2522915, 2522916, 2522…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1878-2016%22
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