The Recall Desk
HighFDA (Devices)·Z-1751-2013·Announced 2013-07-24

Hospira Recalls Symbiq IV Pump Sets Due to Air-in-Line Alarm Risk

Hospira is recalling Symbiq IV pump sets because a defective ball valve may fail to seal, causing air-in-line alarms during fluid administration.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that allows air into the IV line, a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Hospira Inc. is recalling 14,400 units of the Symbiq Pump Set, List No. 19666-28, Lot 87-188-5H. These sterile, prescription-only infusion sets are used for the administration of intravenous fluids. The product was distributed nationwide in the United States, specifically in Iowa, Illinois, Minnesota, South Dakota, and Washington, as well as in Costa Rica.

The recall was initiated after Hospira received reports from customers experiencing air-in-line alarms. A preliminary investigation determined that the ball valve in the drip chamber of these administration sets may not seal as intended. This defect creates a potential for air to enter the line of the administration set.

Healthcare facilities and consumers should stop using the affected Symbiq Pump Sets immediately. Users should check their inventory for the specific List Number 19666-28 and Lot Number 87-188-5H. Affected units should be returned to Hospira or the distributor for credit or replacement in accordance with the recall instructions.

The recalled product

Product
LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pumps and Sets
Hazard
Affected units
14,400

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: 19666-04-28
  • Lot Number: 87-188-5H

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Related recalls

Same manufacturer · Hospira Inc.

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Same hazard · air in line

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