Cl ll Plum A Infusuion pumps

Company: Hospira Inc
Date of Enforcement Report 3/23/2011
Class ll:

PRODUCT
1) Plum A+ Single Channel Infusion Pumps; the pumps were sold under the following configurations: a) list 11971 b) list 11973 – software version 10.3 c) list 12391 – software version 11.3 d) list 20679 – Hospira MedNet Software e) list 20792 – Driver The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield? needleless protection systems makes the Plum A+ a convenient and cost-effective infusion system. Recall # Z-1644-2011;

2) Plum A+3 Triple Channel Infusion Pumps; the pumps were sold under the following configurations: a) list 12348 – software version 10.3; b) list 12618 – software version 11.3; c) list 20678 – Hospira MedNet software Plum A+3 Triple Channel Infusion Pumps; the pumps were sold under the following configurations: a) list 12348 – software version 10.3; b) list 12618 – software version 11.3; c) list 20678 – Hospira MedNet software. Recall # Z-1645-2011;

3) Plum A+ Hyperbaric Single Channel Infusion Pumps; list 11005 The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers. Recall # Z-1646-2011

REASON
Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated February 14, 2011.
Manufacturers: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica;
Hospira Inc, Morgan Hill, CA. FDA initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
167,595 pumps

DISTRIBUTION
Nationwide and Internationally

Software Verification

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