Class 2 Device Recall Plum A Hyperbaric Infusion Pump

• Date Initiated by Firm: February 01, 2013
• Date Posted: July 07, 2017
• Recall Status: Terminated on May 31, 2018
• Recall Number: Z-2675-2017
• Recall Event ID: 64542
• 510(K)Number: K070398
• Product Classification: Pump, infusion - Product Code FRN
• 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.
• Code Information: List number: 11005; Serial Numbers: 16792201 16792202 16792205 16792206 16792208 16792209 16792210 16792211 16792213 16792216 16792217 16792219 16792220 16792222 16792223 16792224 16792225 16792226 16792227 16792228 16792230 16792232 16792233 16792234 16792235 16792236 16792238 16792239 16792240 16792241 16792242 16792244 16792245 16792246 16792248 16792249 16792250 16792251 16792252 16792253 16792254 16792255 16792256 16792257 16792258 16792259 16792260 16792261 16792263 16792264 16792265 16792266 16792268 16792269 16792271 16792272 16792273 18807402 18807405 18807406 18807407 18807408 18807409 18807410 18807413 18807414 18807417 18807418 18807420 18807421 18807423 18807427 18807428 18807429 18807430 18807431 18807432 18807433 18807434 18807439 18807443 18807444 18807446 18807449 18807452 18807453 18807455 18807456 18807459 18807463 18807466 18807472 18807474 18807478 18807484 18807485 18807486 18807490 18807491 18807494 18807496 18807499 18807500 18807501 18807506 18807509 18807510 18807511 18807513 18807514 18807518 18807523 18807524 18807529 18807535 18807536 18807539 18807540 18807541 18807542 18807543 18807545 18807546 18807556 18807557 18807568 18807574 18807575 18807576 18807578 18807581 18807584 18807585 18807586 18807588 18807589 18807590 18807591 18807592 18807596 18807597 18807598 18807599 18807600 18807601 18807602 18807604 18807605 18807607 18807608 18807609 18807610 18807611 18807612 18807613 18807614 18807617 18807618 18807619 18807620 18807623 18807625 18807626 18807627 18807628 18807630 18807631 18807632 18807633 18807634 18807636 18807637 18807639 18807640 18807695 18807696 18807697 18807698 18807699 18807700
• Recalling Firm/ Manufacturer: ICU; 600 N Field Dr; Lake Forest IL 60045-4835
• Manufacturer Reason for Recall: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
• FDA Determined 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 in Commerce: 180 units
• Distribution: Nationwide, Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.