CLASS II Device recall · Reported 9 Nov 2022 · FDA Enforcement Report

Beach Chair Clamp, Beach Chair Shlder Positioner Cmpt recalled

Baxter Healthcare is recalling Beach Chair Clamp, Beach Chair Shlder Positioner Cmpt, distributed in Michigan, Texas, Washington, Wisconsin. The recall was initiated on 20 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 00615521003920, Lot Number: 10-22-140

Quantity recalled13 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0178-2023
FDA event ID: 90848
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 20 Sep 2022
FDA classified: 3 Nov 2022
Reported: 9 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

20 Sep 2022	Recall initiated by company
3 Nov 2022	Classified by FDA	+44 days
9 Nov 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.

Where it was distributed

MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

Michigan Texas Washington Wisconsin

Questions about this recall

Why was it recalled?

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

Which lots are affected?

UDI/DI 00615521003920, Lot Number: 10-22-140

Where was it sold?

MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 90848

This product is part of a recall event; the main page for the event is Simple Clamp, US/Euro Rails, Upper Extremity Distraction Cmpt recalled.

Reported	Class	Recall	Company	Reason	Where
9 Nov 2022	CLASS II	Simple Clamp, US/Euro Rails, Upper Extremity Distraction Cmpt recalled	Baxter Healthcare	Device Malfunction	4 states
9 Nov 2022	CLASS II	Allen Standard Starburst, Mayfield/Doro recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	4 states
9 Nov 2022	CLASS II	Allen Advance Table, Rsp-advance Table: a) recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	4 states
9 Nov 2022	CLASS II	Allen Life Assist Beach Chair, Bcssp-beach Chair recalled	Baxter Healthcare	Device Malfunction	4 states
9 Nov 2022	CLASS II	C-Flex Polar Head Positnr-Device Only, Ssp-neurosurgical Headrest recalled	Baxter Healthcare	Device Malfunction	4 states

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All 565

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All 3,809

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