Recall Z-1878-2016 ยท LDS Device, Pasteurization, Hot Water
Natus Medical Incorporated
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
| Date | Jun 1, 2016 (initiated Apr 22, 2016) |
| Status | Terminated |
| 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. |
| Root cause | 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 & 4 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.