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.
What this means for you
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, subcutaneo
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Pump
- Affected units
- 4,182
Distribution
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 →Related recalls
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- HighCME America Recalls Neofeed Syringe Pumps Due to Motor Wear and Cracks
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- SevereCME America T-Syringe Pump Recall for Motor Wear and Fluid Damage
FDA (Devices) · 2020-12-09
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