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Non-Adhesive Wrap

SenTec AG · Model 103520 · UDI-DI 07640121881039

DPZ LPP LKD KLK DQA Prescription

510(k) clearances

115

Adverse events (4 deaths)

Recalls

Facilities

Description

Sentec’s Non-Adhesive Wrap is intended to be wrapped around the thigh of neonatal patients with very sensitive/fragile skin for subsequent attachment of Sentec Sensors. Sentec’s Non-Adhesive Wrap is a non-adhesive application ring, single-patient use up to 24 hours, recommended for preterm / neonatal patients.

Recalls

Date	Firm	Reason
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2011-04-08	GE Healthcare, LLC	The plastic enclosure on the external power supply of the TruSat Pulse Oximeter is prone to breakage, and overheating. The issue may impact patient or user safety. Potential for s

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.