The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0070-2013·Announced 2012-10-31

Hospira Symbiq Infusion Pump Recalled for Touchscreen Malfunctions

Hospira is recalling Symbiq Two Channel Infusers because the touchscreen may fail to respond or register incorrect values, potentially causing medication delivery errors.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a…"

Plain-English summary

Hospira Inc. is recalling 14,067 units of the Symbiq Two Channel Infuser, a prescription medical device used to administer intravenous fluids and medications. The recall covers devices with List Number 16027-01 and all serial numbers. These units were distributed nationwide in the United States, in Puerto Rico, and internationally to Canada.

The recall is due to a defect where the pump's touchscreen may not respond to user selection, may experience a delayed response, or may register a different value than the one selected by the user. If the touchscreen fails to respond to user input, it could result in a delay in therapy or the over-delivery or under-delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion.

Healthcare providers and facilities using these devices should stop using the affected Symbiq Two Channel Infusers and contact Hospira for instructions on how to proceed. The source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications…
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
14,067

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • List Number 16027-01
  • all serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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