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FDA Medical Device Recalls (openFDA)

ICU: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

Recall number
Z-2677-2017
Recalling firm
ICU
Product
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.
Status
Terminated
Initiated
2013-02-01
Posted
2017-07-07
Terminated
2018-05-31
Reason
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Root cause
Other
Action
Hospira has contracted with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating they have received the letter, and notified their customers. The customers will also be asked to supply the number of Plum A+ infusers at their facility.
Quantity
71 units
Distribution
Nationwide, Worldwide
Lot, serial or model codes
List number: 11973 Serial Numbers 12570148 12570150 12570154 12570163 12570170 12570177 12570204 12570211 12570212 12570255 12570270 12570319 12570359 12570385 12570413 12570425 12570455 12570487 12570662 12570695 12570854 12570915 12571080 12571243 12571437 12571631 12571692 12571776 12571826 12571835 12571837 12571842 12571877 12571880 12571886 12572317 12572369 12572586 12572909 12573547 12573567 12573837 12573990 12574424 12574501 12574524 12574556 12574599 12574619 12574731 12574749 12574853 12574858 12574860 12574865 12574961 12575626 12575698 12575886 12576125 12576443 12576485 12576518 12576593 12576609 12576710 12576722 12577271 12577685 12578856 12579183
510(k) numbers
["K070398"]
PMA numbers
not on file
Product code
FRN
Firm FEI
3013319212
Firm city
Lake Forest
Firm state
IL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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