T-Syringe Pump - T34L PCA recalled by CME America

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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).

Where it was distributed

Worldwide distribution - U.S. Nationwide distribution including in the states of 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 country of Canada.

Nationwide AlaskaArizonaCaliforniaColoradoConnecticutFloridaIdahoIllinoisKansasLouisianaMassachusettsMichiganMissouriMontanaNorth CarolinaNebraskaNevadaOklahomaOregonPennsylvania