Home / Recalls / Natus Medical Incorporated / Z-2701-2017

Z-2701-2017 Class II Terminated

Recalled by Natus Medical Incorporated — Seattle, WA

FDA device recall Z-2701-2017 was initiated by Natus Medical Incorporated on May 22, 2017 and is designated Class II. 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 … The recall status is terminated (terminated July 3, 2019). Affected quantity: total 275 units (97 units in US and 178 units international).

Recall Details

Product Type
Devices
Report Date
July 19, 2017
Initiation Date
May 22, 2017
Termination Date
July 3, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
total 275 units (97 units in US and 178 units international)

Product Description

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

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.

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.

Code Information

************Serial numbers of affected units distributed to US government*************** 3056 and 9199. ************Serial numbers of affected units distributed to US consignees*************** 3039, 3041, 3043, 3045, 3050, 3055, 3062, 3071, 3079, 3083, 3084, 3096, 3100, 3113, 3143, 3153, 3155, 3162, 3165, 3174, 3188, 3192, 3194, 3195, 3223, 3224, 3229, 3232, 3238, 3240, 3249, 3260, 3265, 9197, 9198, 03003, 03004, 03012, 03020, 03022, 03028, 03034, 03047, 3002, 3006, 3009, 3013, 3029, 3035, 3044, 3046, 3047, 3048, 3052, 3059, 3063, 3084, 3085, 3091, 3091, 3094, 3099, 3101, 3110, 3118, 3134, 3136, 3142, 3145, 3148, 3149, 3156, 3161, 3169, 3171, 3173, 3180, 3181, 3183, 3185, 3189, 3190, 3198, 3225, 3227, 3237, 3239, 3241, 3266, 3277, 3278, 3279, 3281, 3345, and 9198. ************Serial numbers of affected units distributed to international consignees******* 3019, 3036, 3040, 3049, 3051, 3053, 3054, 3057, 3061, 3064, 3065, 3067, 3072, 3073, 3074, 3077, 3078, 3080, 3081, 3082, 3083, 3084, 3086, 3087, 3088, 3089, 3090, 3092, 3093, 3097, 3098, 3102, 3103, 3104, 3106, 3107, 3109, 3113, 3116, 3117, 3120, 3123, 3124, 3129, 3130, 3131, 3132, 3135, 3137, 3138, 3139, 3144, 3146, 3147, 3150, 3151, 3152, 3154, 3158, 3163, 3164, 3166, 3167, 3172, 3172, 3175, 3177, 3178, 3179, 3182, 3186, 3187, 3193, 3196, 3204, 3206, 3208, 3210, 3211, 3211, 3215, 3217, 3218, 3219, 3220, 3221, 3222, 3226, 3228, 3230, 3231, 3233, 3234, 3235, 3242, 3243, 3244, 3245, 3246, 3247, 3250, 3251, 3252, 3253, 3254, 3257, 3261, 3264, 3267, 3268, 3269, 3270, 3272, 3273, 3274, 3276, 3280, 03008, 03014, 03017, 03018, 03021, 03023, 03024, 03027, 03175, 03200, 3025, 3035, 3037, 3058, 3060, 3068, 3070, 3075, 3076, 3095, 3105, 3108, 3111, 3114, 3115, 3119, 3121, 3122, 3125, 3126, 3128, 3133, 3140, 3141, 3157, 3159, 3160, 3168, 3170, 3176, 3184, 3191, 3200, 3201, 3202, 3203, 3205, 3207, 3209, 3212, 3213, 3214, 3216, 3236, 3248, 3258, 3259, 3262, 3271, 3275, and 9200.

Other recalls by Natus Medical Incorporated

  • Z-0634-2024 Class II — External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only (November 28, 2023)
  • Z-0635-2024 Class II — EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only (November 28, 2023)
  • Z-0735-2023 Class II — The Natus Cranial Access Kit is designed to be a complete, single use and dispos (November 18, 2022)
  • Z-1924-2017 Class II — Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 a (April 3, 2017)
  • Z-0770-2017 Class II — Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to pr (October 28, 2016)
  • Z-0769-2017 Class II — Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherap (September 16, 2016)
  • Z-0056-2017 Class II — The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numb (August 25, 2016)
  • Z-1878-2016 Class II — Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter C (April 22, 2016)
  • Z-2001-2016 Class II — Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly (April 11, 2016)
  • Z-1363-2016 Class II — Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator. (January 8, 2016)

FDA data resources