Alaris Syringe Pump Module Class I

Company: Carefusion
Date of Enforcement Report 1/25/2017
Class I:

PRODUCT

Product Description: Alaris Syringe Pump Module (Large Volume Pump), Model No. 8100 and AIL sensor kits
Recall number Z-0950-2017

REASON
CareFusion is recalling the Alaris Syringe Pump because of a faulty Air-In-Line (AIL) sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. If the AIL sensor is faulty, the false alarm may be repeated and require the health care provider to clear the alarm to restart the infusion. Interruption of infusion could lead to serious adverse health consequences or death.

RECALLING FIRM/MANUFACTURER
CareFusion San Diego, CA12/2/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
382,635 units

DISTRIBUTION
Nationwide

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15148 Springview St
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Partners located in the US (CA, FL, MA, MN) and Italy.