Company: Draegar Medical Systems, Inc.
Date of Enforcement Report 4/19/2017
Class lI:
PRODUCT
Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus.
Recall Number Z-1772-2017
REASON
It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
RECALLING FIRM/MANUFACTURER
Draegar Medical Systems, Inc., Andover, MA on 3/28/2017. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
2156
DISTRIBUTION
Nationwide and Internationally
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