CME America T-Syringe Pump Recall for Motor Wear and Fluid Damage
CME America is recalling T34L PCA syringe pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may damage hardware.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect (under-infusion without alarm) that poses a significant risk of harm to patients, meeting the criteria for a Severe rating.
Plain-English summary
CME America, LLC is recalling 4,182 T-Syringe Pump - T34L PCA units. 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 due to two specific 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 units were distributed worldwide, including nationwide in the United States and in Canada. Specific serial numbers and part numbers are listed in the agency's recall record. Users should stop using the affected pumps and contact CME America for further instructions.
The recalled product
- Product
- CME America T-Syringe Pump - T34L PCA - 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 — 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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