The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic recall
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and…
Why was The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
************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.
- Product
- The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and…
- Recalling firm
- Natus Medical Incorporated
- 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, India, Indonesia, Japan, Korea, Malaysia, Mexico, Panama, Peru, Qatar, Saudi Arabia, Taiwan, Thailand, and Viet Nam.
- Recall date
- July 19, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)