Baxter Healthcare Corporation: 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.

Agency Publication Date: November 3, 2022

Affected Products

Product: Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table

a) UDI/DI 00615521003012, Serial Number 122190000035, Lot Number 122220000528 b) UDI/DI 00615521003036, Serial Number 122230000655, Lot Number 122180001460

Lot Numbers:

Number

Product: C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,

UDI/DI 00615521002701, Lot Numbers: 122190000182, 122190001101

Lot Numbers:

Numbers

Product: Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.

UDI/DI 00615521002725, Lot Number: 22-123

Lot Numbers:

Number

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

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

Lot Numbers:

Number

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.

UDI/DI 00615521004125, Lot Number: 22-123

Lot Numbers:

Number

Product: Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.

UDI/DI 00615521012731, Lot Number: 22-124

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90848

Status: Active

Manufacturer: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 6 products (2 units; 2 units; 2 units; 13 units; 1 unit; 1 unit)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table

a) UDI/DI 00615521003012, Serial Number 122190000035, Lot Number 122220000528 b) UDI/DI 00615521003036, Serial Number 122230000655, Lot Number 122180001460

Lot Numbers:

Number

Product: C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,

UDI/DI 00615521002701, Lot Numbers: 122190000182, 122190001101

Lot Numbers:

Numbers

Product: Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.

UDI/DI 00615521002725, Lot Number: 22-123

Lot Numbers:

Number

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

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

Lot Numbers:

Number

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.

UDI/DI 00615521004125, Lot Number: 22-123

Lot Numbers:

Number

UDI/DI 00615521012731, Lot Number: 22-124

Lot Numbers:

Number