Company: Hospira Inc.
Date of Enforcement Report 10/26/11
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-3284-2011
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 The Plum A+3 is a dual-line triple channel 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+3 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+3 a convenient and cost-effective infusion system. Recall # Z-3285-2011;
3) Plum A+ Hyperbaric Single Channel Infusion Pumps; list 11005. Recall # Z-3286-2011
REASON
Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged the clamp prior to opening the cassette door, unrestricted flow may occur..
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter dated September 16, 2011.
Manufacturers: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia,
Costa Rica;
Manufacturer: Hospira Inc., Morgan Hill, CA. Firm initiated recall is ongoing.|
VOLUME OF PRODUCT IN COMMERCE
290,217 pumps
DISTRIBUTION
Nationwide and Internationally
