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...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0434-2013.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0434-2013.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0434-2013.
Sentec AG
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Sentec Ag Recall FAQ
Sentec Ag is the subject of a respiratory devices safety report: 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.... The notice was published on November 5, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 265 units are potentially affected.