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ADULT VEL.STRAP KIT 1.5",SIZE 1

Respironics, Inc. · Model VELCRO STRAP · UDI-DI 00606959011007

BZQ Prescription
1
510(k) clearances
127
Adverse events (11 deaths)
3
Recalls
110
Facilities

Description

ADULT VEL.STRAP KIT 1.5",SIZE 1

Recalls

DateFirmReason
2010-12-21Salter Laboratories, Division of Regulatory AffairsThe incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment.
2004-06-04Respironics, Inc.Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.
2004-05-24CAS Medical Systems, Inc.Device may not alarm for %SpO2 value limit violations if a specific feature is enabled

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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.