medical Class II Updated 2020-12-09

CME America, LLC recalls CME America T-Syringe Pump - T34L PCA - Product Usage: infus

Recalled 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, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).


Hazard / Issue

Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model T34L PCA - Part Number(s) (UDI Codes) 100-106PSL (UDI Code: B101100106PSL0) Serial Number: 26486 26485 26484 S93716 100-106PSLM (retired prior to UDI)
View official government recall

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