# FDA recall Z-1768-2019

> **CareFusion 303, Inc.** · Class I · device recall initiated 2018-04-13.

## Product

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

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.

## Key facts

- **Recall number:** Z-1768-2019
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-13
- **Report date:** 2019-07-24
- **Termination date:** 2023-12-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1768-2019

## Citation

> AI Analytics. FDA recall Z-1768-2019. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1768-2019. Source: US FDA. Licensed CC0.

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