Moderate FDA (Devices)·Z-0863-2016·Announced 2016-03-02

Hospira Symbiq Infusion Pumps Recalled for Missing Rubber Stop Pad

Hospira is recalling 6,634 Symbiq infusion pumps because the pole clamp assemblies may be missing a rubber stop pad. The devices were distributed to healthcare facilities in the U.S. and Canada.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries or illnesses. The hazard involves a missing component (rubber stop pad) which is a mechanical defect without reported harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Hospira Inc. is recalling 6,634 units of the Symbiq infusion pump. The recall is due to a potential defect where the pole clamp assemblies may be missing the rubber stop pad. The Symbiq infusion pump is a medical device used in healthcare facilities to pump fluids into a patient in a controlled manner. It is intended primarily for use in hospital settings but can also be used in other acute and non-acute areas, including nursing homes, mobile intensive care, ambulatory infusion centers, hospice, sub-acute facilities, outpatient and surgical centers, long-term care, urgent care, transport, and physician offices.

The affected units are identified by Lot Codes 16026 and 16027, along with specific serial numbers listed in the official recall documentation. The devices were distributed to U.S. consignees nationwide and to foreign consignees in Canada. The source text does not report any illnesses, injuries, or deaths associated with this defect.

Healthcare facilities should check their inventory for Symbiq infusion pumps matching the affected lot codes and serial numbers. If a device is found to be affected, it should be removed from service and returned to Hospira Inc. according to the instructions provided by the manufacturer. The recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences.

The recalled product

Product: The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobi
Manufacturer: Hospira Inc.
Category: Medical Device — Infusion Pump
Hazard: mechanical-defect
Affected units: 6,634

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 (20)

Lot Code 16026 &16027 with the following serial numbers: 14339221
14339224
14339232
14339261
14339275
14339296
14339308
14339321
14339335
14339349
14339353
14339357
14339371
14339372
14339378
14339387
14339391
14339396
14339401
14339504

Distribution

Distributed nationwide across the United States.

Same manufacturer · Hospira Inc.

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