The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0526-2021·Announced 2020-12-09

CME America Recalls NeoThrive Syringe Pumps Due to Motor Wear

CME America is recalling 4,182 NeoThrive 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 agency classification is FDA Class II. The hazard involves a medical device failure (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 units of the NeoThrive 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 clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, and intra-operative sites.

The recall is issued 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 damaged 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. The affected model is the NeoThrive with Part Number 100-101PSL.

The recalled product

Product
CME America T-Syringe Pump - NeoThrive - 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

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 NeoThrive - Part Number(s) 100-101PSL UDI Code: Retired prior to UDI

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 →

Related recalls

Same manufacturer · CME America, LLC

See all →

Same hazard · under infusion

See all →

Similar recalls