Agency classClass IIOur severity:High FDA (Devices)·Z-0829-2022·Announced 2022-04-06

Liko Universal Twinbar 670 QRH Patient Lift Accessory Recalled for Fall Risk

Baxter Healthcare Corporation is recalling 1,399 Liko Universal Twinbar 670 QRH patient lift accessories due to an incorrect center bolt used during assembly. The defect could cause a patient to fall during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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: This is a Class II medical device recall involving a mechanical failure that poses a risk of patient fall, a significant safety concern for dependent patient populations. However, no illnesses or injuries have been reported, placing it in the High category rather than Severe.

Plain-English summary

Baxter Healthcare Corporation is recalling the Liko Universal Twinbar 670 QRH, an accessory used with Liko lift devices (model numbers 3156087 and P3156087). Approximately 1,399 units are affected. The recalled twinbars were manufactured before October 28, 2021.

An incorrect center bolt was used during the assembly of the product. This mechanical defect could cause the twinbar to fail during patient transfers, potentially resulting in a patient fall.

The product was distributed worldwide and within the United States to customers in multiple states including California, Texas, Florida, New York, and many others. Government facilities also received the product.

Patients, caregivers, and healthcare facilities using this product should stop using the affected twinbars immediately and contact Baxter Healthcare Corporation for a replacement or repair. Facilities should verify their unit's manufacturing date and model number against the recall details provided by the manufacturer.

The recalled product

Product: Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Patient Lift Accessory
Hazard: mechanical-failure
fall-risk
Affected units: 1,399

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)

Manufactured before 28OCT2021
UDI 00887761982468

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Same manufacturer · Baxter Healthcare Corporation

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