Replacement HEPA filter 의 리콜

Recall

74004

Class 2

Z-1878-2016

2016-04-22

2016-06-01

Terminated

United States

2016-12-16

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145885

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.

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.