The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0529-2021·Announced 2020-12-09

CME America T-Syringe Pump Recalled for Motor Wear and Fluid Damage

CME America is recalling 4,182 T-Syringe Pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may crack hardware.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a failure (under-infusion without alarm) poses a risk of harm to patients, but the source text does not report any specific injuries, illnesses, or fatalities, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

CME America, LLC is recalling 4,182 T-Syringe Pumps, specifically the Ameritus 1st Enteral Pump model. The recall is due to two identified issues: wear and tear of the pump motor block mechanism, which may cause under-infusion situations without the pump alarm being generated, and cracks in the pump hardware that may be damaged by fluid used during the cleaning process.

The affected pumps were distributed worldwide, including nationwide distribution in the United States and in Canada. The specific serial numbers and part numbers for the affected units are listed in the official recall documentation.

Healthcare facilities and users should stop using the affected pumps immediately and contact CME America for further instructions on the recall process.

The recalled product

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…
Manufacturer
CME America, LLC
Category
Medical Device — Infusion Pump
Hazard
Affected units
4,182

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Part of a larger recall action

This product is one of 6 recalled by CME America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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