Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Class I - DangerousWhat Should You Do?
- Check if you have this product: During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers. ** US Serial numbers: 2326370, 2326382, 2326385, 2326387, 3668143, 2326400, 2326401, 2326402, 2326416, 2326418, 2326419, 2326423, 2326647, 2326664, 2326819, 2326821, 2326834, 2326837, 2326842, 2326873, 2326882, 2326883, 2326926, 9300064, 9300081, 9300083, 9300117, 9300149, 9300162, 9300163, 9300164, 9300171, 9300174, 9300176, 9300284, 9300302, 9300313, 9300317, 9300333, 9300334, 9300485, 3669844, 9300531, 9300532, 9300533, 9300534, 9300535, 9300538, 3686560, 4011408, 3696229, 3000933, 4122102, 4123517, 4123611, 4123651, 4123981, 4124350, 4124764, 4124999, 4125045, 4125149, 4125888, 4125923, 4126044, 4126051, 4126072, 4126073, 4126076, 4126077, 4126092, 4126093, 4126127, 4126128, 4126131, 4126146, 4126147, 4126148, 4126149, 4126151, 4126205, 4126206, 4126208, 4126212, 4126213, 4126214, 4126285, 4126286, 4126287, 4126288, 4126290, 4126299, 4126302, 4126315, 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- CareFusion 303, Inc.
- Reason for Recall:
- Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Product Codes/Lot Numbers:
During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers. ** US Serial numbers: 2326370, 2326382, 2326385, 2326387, 3668143, 2326400, 2326401, 2326402, 2326416, 2326418, 2326419, 2326423, 2326647, 2326664, 2326819, 2326821, 2326834, 2326837, 2326842, 2326873, 2326882, 2326883, 2326926, 9300064, 9300081, 9300083, 9300117, 9300149, 9300162, 9300163, 9300164, 9300171, 9300174, 9300176, 9300284, 9300302, 9300313, 9300317, 9300333, 9300334, 9300485, 3669844, 9300531, 9300532, 9300533, 9300534, 9300535, 9300538, 3686560, 4011408, 3696229, 3000933, 4122102, 4123517, 4123611, 4123651, 4123981, 4124350, 4124764, 4124999, 4125045, 4125149, 4125888, 4125923, 4126044, 4126051, 4126072, 4126073, 4126076, 4126077, 4126092, 4126093, 4126127, 4126128, 4126131, 4126146, 4126147, 4126148, 4126149, 4126151, 4126205, 4126206, 4126208, 4126212, 4126213, 4126214, 4126285, 4126286, 4126287, 4126288, 4126290, 4126299, 4126302, 4126315, 4126318, 4126358, 4126360, 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Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2716-2020
Related Recalls
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
BD Pyxis Pro MedStation Main, REF: 1155-00
CareFusion 303
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.