🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: May 22, 2017 Natus Medical Incorporated Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    ************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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Natus Medical Incorporated
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

************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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2701-2017

Related Recalls

The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various components of the kit are comprised to make it convenient for the practitioner to have all that they need in one place for fast and efficient intracranial access. cerebral spinal fluid (CSF).

Natus Medical Incorporated

Class I - Dangerous

Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.

Nov 18, 2022 Diagnostic Equipment Nationwide View Details →