Z-1768-2019 Class I Terminated
Recalled by CareFusion 303, Inc.
— San Diego, CA
FDA device recall Z-1768-2019 was initiated by CareFusion 303, Inc. on Apr 13, 2018 and is designated Class I. Reason for recall: The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as… The recall status is terminated (terminated Dec 26, 2023). Affected quantity: 607618.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 24, 2019
- Initiation Date
- Apr 13, 2018
- Termination Date
- Dec 26, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 607618
Product Description
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N 10942012, P/N 49000007, and P/N 49000203), and Alaris Pump module Bezel Kit Assembly (P/N 10964559 and P/N 49000204). Product Usage: The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural. There are 6 bezel posts on the Alaris Pump bezel assembly.
Reason for Recall
The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.
Distribution Pattern
Worldwide Distribution - U.S. Nationwide CA, TX, NC, AL, ID, TN, IN, MA, UT, HI, NH, PA, IL, OR, FL, MI, VA, AR, OH, GA, NY, MD, MN, NM, AZ, KY, WI, NE, MS, DC, MO, KS, SC, LA, MT, WA, NJ, CO, CT, OK, AK, AS, CU, DE, GU, IA, ME, MP, ND, NV, PR, SD, VT, WV, WY; OUS: AE, AU, BH, CA, CH, CN, GI, IL, IN, KW, MX, MY, NL, NZ, PH, PK, QA, SA, SG, TW, and ZA.
Code Information
All pumps manufactured between April 2011 and June 2017, that have bezel mechanical assemblies manufactured with FR-110 plastic resin. And all pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1768-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.