Z-2701-2017 Class II Terminated
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.