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Terminated

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 208/120) REFURB 007170 PM3 ASSY (8.3KW 200V DELTA) 007171 PM3 ASSY (9KW 220V SING PH) 52640 PASTEURMATIC 3000 W/O BASKETS 52640R PM 3000 w/o Baskets Refurb 52640-200 PM 3000 W/O BASKETS 200V 52640-220 PM 3000 W/O BASKETS 220V 52641 PASTEURMATIC 3000 W/BASKET S 52641R PM 3000 w/ Baskets Refurb 52641-200 PM 3000 W BASKETS 200V 52641-220 PM 3000 W/ BASKETS 220V 52650 PASTEURMATIC 3500 W/O BASKET 52651 PASTEURMATIC 3500 W/BASKETS S

FDA Recall Z-2701-2017 · Posted 2017-06-02

Recalling FirmNatus Medical Incorporated
Recall StatusTerminated
Product CodeMEC
Date Initiated2017-05-22
Date Terminated2019-07-03
Product Quantitytotal 275 units (97 units in US and 178 units international)

Reason for Recall

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.

Firm 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 suggest there is a safety risk associated with the Olympic Pasteurmatic" 3000/3500 System device, nor have there been any safety incidences reported to Natus. Natus apologizes for any inconvenience. Please understand that this is part of our commitment to providing only the highest quality products and information to our customers. Please contact us at [email protected] or (866) 940-7143 option #2 if you have any further questions.

Root Cause

Device Design

Distribution Pattern

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, India, Indonesia, Japan, Korea, Malaysia, Mexico, Panama, Peru, Qatar, Saudi Arabia, Taiwan, Thailand, and Viet Nam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081094OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500Olympic Medical Corp. · 2008-06-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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