CLASS II Device recall · Reported 20 Nov 2013 · FDA Enforcement Report

The Plum A+ Hyperbaric Infusion System is a cassette based recalled

Hospira is recalling The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system, distributed nationwide in the US. The recall was initiated on 1 Feb 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 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 , 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

Quantity recalled179 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0283-2014
FDA event ID: 64263
Recalling firm: Hospira, Lake Forest, IL
Classification: Class II
Status: Terminated
Recall initiated: 1 Feb 2013
FDA classified: 14 Nov 2013
Reported: 20 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Syringes & Needles

Timeline

1 Feb 2013	Recall initiated by company
14 Nov 2013	Classified by FDA	+286 days
20 Nov 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Hyperbaric Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Where it was distributed

Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Is The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system recalled?

Yes. Hospira recalled The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system on 1 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-0283-2014.

Why was it recalled?

Which lots are affected?

1) 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 , 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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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