Recall Z-2109-2023— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2023-05-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Allen Advance Chest Support with Pad. Reason: Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-18
- Firm location
- Deerfield, IL, United States
Product description
Allen Advance Chest Support with Pad
Reason for recall
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
Data sourced from openFDA. This site is unofficial and independent of the FDA.