CME America T-Syringe Pump T34 Recalled for Motor Wear and Hardware Cracks
CME America is recalling 4,182 T-Syringe Pump T34 units 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, and the hazard involves a risk of harm (silent under-infusion) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
CME America, LLC is recalling 4,182 units of the T-Syringe Pump - T34. The recall is due to two specific defects: 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 pumps 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, in close proximity to nerves, and into an intra-operative site. The devices were distributed worldwide, including nationwide in the United States and in Canada.
Healthcare facilities and users should stop using the affected T-Syringe Pump T34 units immediately and contact CME America, LLC for further instructions on the recall process. The recall number is Z-0530-2021.
The recalled product
- Product
- CME America T-Syringe Pump - T34 - 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 (3)
- Model T34 - Part Number(s) 100-100PS
- 100-100PSA
- 100-100POBSC
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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