Recall Z-2701-2017 ยท MEC Disinfector, Medical Devices
Natus Medical Incorporated
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160 - ~170 F for 30 minutes. Catalog Number/Description: 007168 PM3500 ASSY (15KW 208/120V) 007169 PM3000 ASSY (9KW 208/120V) 007169R PM3 (9KW 2
| Date | Jun 2, 2017 (initiated May 22, 2017) |
| Status | Terminated |
| Reason | Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices. |
| Root cause | Device Design |
| Action | Natus Medical sent an URGENT: RECALL NOTIFICATION MEDICAL DEVICE RECALL letter dated May 2017. Please refer to the accompanying Instructions to Disable the Pasteurmatic (DOC-022838), then complete and return the attached reply form. Should you require assistance in decommissioning your affected system please indicate option 2 on the reply form and you will be contacted to schedule an in- service. Natus may reimburse facilities for Olympic Pasteurmatic" 3000/3500 System purchases based on the age of the affected system as determined by the system serial number. There is no evidence to sug |
| Quantity | total 275 units (97 units in US and 178 units international) |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AR, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, and WV and in the following countries: Canada, Colombia, Costa Rica, Ecuador, Hong Kong, Indi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081094 | OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 Olympic Medical Corp., Jun 20, 2008 |