Z-2736-2020 Class I Terminated
FDA device recall Z-2736-2020 was initiated by CareFusion 303, Inc. on Jun 30, 2020 and is designated Class I. 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… The recall status is terminated (terminated Apr 23, 2024). Affected quantity: 1093588.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 12, 2020
- Initiation Date
- Jun 30, 2020
- Termination Date
- Apr 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1093588
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.
Distribution Pattern
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
Code Information
All serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2736-2020
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026