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.
FDA Recall Z-2682-2017 · Posted 2017-07-07
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Recalling FirmICU
Recall StatusTerminated
Product CodeFRN
Date Initiated2013-02-01
Date Terminated2018-05-31
Product Quantity7351 units
Reason for Recall
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide, Worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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