Sentec AG: Medical Device Recall in 2012 - (Recall #: Z-0434-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.

Product Classification:

Class II

Date Initiated: November 5, 2012

Date Posted: November 28, 2012

Recall Number: Z-0434-2013

Event ID: 63631

Reason for Recall:

A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.

Status: Terminated

Product Quantity: 265 boxes (5 per box)

Code Information:

Lot numbers: 1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F

Distribution Pattern:

Distributed only in MO.

Voluntary or Mandated:

Voluntary: Firm initiated