FDA Device Recall Z-0010-2012: Hospira Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0010-2012.

Recall Res Number

Z-0010-2012

Recalling Firm / Manufacturer

Hospira Inc.

FEI Number

3013319212

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2011-09-16

Date Posted

2011-10-04

Date Terminated

2016-11-07

Product Code

FRN

Event Number

59956

Product Quantity

24,992 pumps

Product Description Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; 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 Product Usage: 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.

Reason for Recall Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting.

Action Details The firm, Hospira sent "URGENT DEVICE RECALL" letters dated September 16, 2011 to all affected customers. The letters identified the products, problem and action(s) to be taken. The customers were instructed to read the information provided carefully, complete the attached Reply Form and return it to Hospira via fax at 1-888-345-5358. The letter states that a software upgrade to address the issue is currently being developed. Customers were instructed to notify their consignees if they have further distributed the affected product. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for technical assistance. *** Follow-up letters dated June 26, 2012 were sent to the accounts listing the device modules with software versions v13.2, v13.3, v13.40 and v13.5 that will require the software upgrade. ***

Distribution Pattern Worldwide Distribution - USA (nationwide) including Puerto Rico and the US Virgin Islands, and countries of: Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United kingdom, United Arab Emirates, Uruguay and Vietnam.

Code Information / Serial Numbers a) list 12348 - serial numbers 0013740398 through 0013741025; b) list 12618 - serial numbers 0014040007 through 0018857420; c) list 20678 - serial numbers 0015543071 through 0019655471

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Medical Device Recall: Z-0010-2012

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer