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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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