FDAClass IINovember 28, 2012

SenTec V-Sign Membrane Changer Insert recall

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…

Why was SenTec V-Sign Membrane Changer Insert recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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…
Recalling firm
Sentec AG
Quantity
265 boxes (5 per box)
Distribution
Distributed only in MO.
Recall date
November 28, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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