CME America T-Syringe Pump Recalled for Motor Wear and Hardware Damage
CME America is recalling T-Syringe Pumps because motor wear may cause silent under-infusion 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 is classified as FDA Class II. The hazard involves a risk of harm (silent under-infusion of medication) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
CME America, LLC is recalling the CME America T-Syringe Pump -T34L. The recall involves a total of 4,182 pumps across all models. These devices are used for the infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through various routes of administration, including intravenous and subcutaneous.
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, cracks in the pump hardware may be caused by fluid used during the cleaning process.
The affected pumps were distributed worldwide, including nationwide in the United States and in Canada. Specific U.S. states listed in the distribution pattern include AZ, AK, CA, CO, CT, FL, ID, IL, KS, LA, MA, MI, MO, MT, NC, NE, NV, OH, OK, OR, PA, TN, TX, WA, and WI. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- CME America T-Syringe Pump -T34L - 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, intr
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion 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 (1)
- Model TR34L - Part Number(s) 100-100PSLA
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 T-Syringe Pump T34 Recalled for Motor Wear and Hardware Cracks
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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
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