Recall Z-1878-2016— Natus Medical Incorporated
Class II · Terminated
Class II FDA medical device recall by Natus Medical Incorporated, initiated 2016-04-22, terminated 2016-12-16. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Natus Medical Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-22
- Terminated
- 2016-12-16
- Firm location
- Seattle, WA, United States
Product description
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.