The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0527-2021·Announced 2020-12-09

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
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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