Company: Nellcor Puritan Bennett Inc. (dba Covidien LP).
Date of Enforcement Report 11/6/2014
Class I:

PRODUCT

Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Recall Number Z-0112-2015

REASON
A software issue may lead to ventilator inoperative situations.

RECALLING FIRM/MANUFACTURER
Nellcor Puritan Bennett Inc. (dba Covidien LP, Boulder, CO) on 10/1/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
324 units

DISTRIBUTION
Nationwide and Internationally

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