# FDA recall Z-0529-2021

> **CME America, LLC** · Class II · device recall initiated 2020-07-30.

## Product

CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

## Reason for recall

Multiple reasons:  1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated.  2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, AK, CA, CO, CT, FL, ID, IL, KS, LA, MA, MI, MO, MT, NC, NE, NV, Oh, OK, OR, PA, TN, TX, WA, and WI. The country of Canada.

## Key facts

- **Recall number:** Z-0529-2021
- **Recalling firm:** CME America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-30
- **Report date:** 2020-12-09
- **Termination date:** 2022-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Golden, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0529-2021

## Citation

> AI Analytics. FDA recall Z-0529-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0529-2021. Source: US FDA. Licensed CC0.

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