Alaris Pump Module Model 8100
Reported: August 12, 2020 Initiated: June 30, 2020 #Z-2736-2020
Product Description
Alaris Pump Module Model 8100
Reason for Recall
Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.
Details
- Recalling Firm
- CareFusion 303, Inc.
- Units Affected
- 1093588
- Distribution
- US: CA, FL, IN, TX, NC, LA, SC, VA, PA, OK, AZ, IL, KY, UT, AL, GA, TN, MA, MI, OH, AK, OR, MS, CO, NY, WI, KS, MO, MD, NV, AR, AS, ID, VT, NE, NJ, DC, HI, CT, MT, WV, NH, WA, DE, ME, NM, MN, WY, IA, SD, ND, MP, PR, GU. OUS: NL, MX, AU, MY, NZ, ZA, GB, FR, CH, CN, SG, TW, CA, IL, KW, QA, DE, BH, IN, SA, GI, AE, PK, PH, BE
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Alaris Pump Module Model 8100. Recalled by CareFusion 303, Inc.. Units affected: 1093588.
Why was this product recalled? ▼
Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 12, 2020. Severity: Critical. Recall number: Z-2736-2020.
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