The Recall Desk
HighFDA (Devices)·Z-0179-2023·Announced 2022-11-09

Allen Life Assist Beach Chair Adhesive Cure Failure Recall

Baxter Healthcare is recalling the Allen Life Assist Beach Chair due to adhesive on fasteners that may not cure correctly, potentially compromising the device's mechanical integrity during surgical procedures.

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: This FDA Class II recall involves a surgical positioning device where a mechanical defect could compromise stability during procedures. No injuries or incidents are reported. Per the rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High).

Plain-English summary

Baxter Healthcare Corporation is recalling the Allen Life Assist Beach Chair (BCSSP-BEACH CHAIR, REF A-91501) used for positioning patients during orthopedic surgical procedures in the Fowler or beach chair position.

The recall is due to adhesive applied to screws and bolts that may not cure correctly. This defect could result in loss of holding force and reduced mechanical integrity of the fasteners, potentially affecting the stability of the chair during surgical use.

The affected product was distributed in the United States and internationally to Germany, Japan, South Korea, Sweden, and South Africa. The recalled device is identified by Lot Number 22-123 and UDI/DI 00615521004125.

Healthcare facilities with this device should discontinue use and contact Baxter Healthcare Corporation for instructions on replacement or repair.

The recalled product

Product
Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Fowlers or beach chair position.
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Surgical Positioning Equipment
Hazard
Affected units
1

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)

  • UDI/DI 00615521004125
  • Lot Number: 22-123

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 6 recalled by Baxter Healthcare Corporation 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 6 products in this recall →

Related recalls

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · adhesive failure

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