Agency classClass IIOur severity:High FDA (Devices)·Z-0178-2023·Announced 2022-11-09

Beach Chair Clamp Shoulder Positioner recalled for adhesive curing failure

Baxter Healthcare recalls Beach Chair Clamp shoulder positioner components because adhesive on the fasteners may not cure properly, potentially reducing the device's mechanical integrity during surgical procedures.

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 an FDA Class II medical device recall involving a structural integrity hazard (adhesive curing failure). While used in a high-risk surgical setting, the source text reports no injuries, illnesses, or adverse events. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

Baxter Healthcare Corporation is recalling Beach Chair Clamp shoulder positioner components (REF A-90013, #800104). These components are used to position and support patients' heads during surgical procedures.

The adhesive applied to the component's screws and bolts may not cure correctly during manufacturing. As a result, the device may experience loss of holding force and reduced mechanical integrity.

The recalled components (13 units from Lot Number 10-22-140, UDI/DI 00615521003920) were distributed in the United States (Michigan, BA, Wisconsin, Washington, Texas) and internationally (Germany, Japan, South Korea, Sweden, South Africa). Healthcare facilities should verify the lot number of any Beach Chair Clamp shoulder positioner components they have in use.

The recalled product

Product: Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Surgical positioning device
Hazard: adhesive-failure
structural-defect
Affected units: 13

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 00615521003920
Lot Number: 10-22-140

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 →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · adhesive failure