CME America Recalls Neofeed Syringe Pumps Due to Motor Wear and Cracks
CME America is recalling 4,182 Neofeed syringe pumps because motor wear may cause under-infusion without alarms and cracks may allow cleaning fluids to damage 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 or illnesses, fitting 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 units of the Neofeed T-Syringe Pump. These devices are used for the infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through various clinical routes, including intravenous and subcutaneous administration.
The recall is being conducted for two reasons. First, wear and tear of the pump motor block mechanism may cause under-infusion situations without the pump alarm being generated. Second, due to cracks, the pump hardware may be damaged by fluid used during the cleaning process.
The affected units were distributed worldwide, including nationwide in the United States and in Canada. Specific serial numbers and part numbers are listed in the official recall documentation. Healthcare facilities should stop using the affected pumps and contact CME America for instructions on replacement or repair.
The recalled product
- Product
- CME America T-Syringe Pump - Neofeed - 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,
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Syringe Pump
- Affected units
- 4,182
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Neofeed - Part Number(s) 100-109PSL1A
- 100-109PSLA
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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