Recall Z-0179-2023— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-09-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-09-20
- Firm location
- Deerfield, IL, United States
Product description
Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Fowlers or beach chair position.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.