Operating Room Table With Defective Adhesive May Lose Mechanical Integrity
Baxter Healthcare is recalling Allen Advance operating room tables because adhesive securing fasteners may not cure properly, potentially compromising mechanical integrity.
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 a Class II medical device recall for a risk-of-harm product (operating room table with potential mechanical integrity loss during critical surgical use). No hospitalizations, injuries, or illnesses have been reported. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Baxter Healthcare Corporation is recalling Allen Advance operating room tables (Reference A-71100-US #107003 and A-71101-EU #107003) distributed to Michigan, Wisconsin, Washington, and Texas in the United States, and to Germany, Japan, South Korea, Sweden, and South Africa internationally. Two units are affected.
The adhesive applied to the table's screws and bolts as an additional holding force may not cure correctly. Improper curing could result in loss of holding strength and reduced mechanical integrity of the fastened connections.
Healthcare facilities and surgical centers currently using these affected tables should immediately discontinue use and contact Baxter Healthcare Corporation for guidance on repair or replacement. The affected serial numbers are 122190000035 (Lot 122220000528) and 122230000655 (Lot 122180001460).
The recalled product
- Product
- Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 2
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 (5)
- a) UDI/DI 00615521003012
- Serial Number 122190000035
- Lot Number 122220000528 b) UDI/DI 00615521003036
- Serial Number 122230000655
- Lot Number 122180001460
Distribution
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.
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- Severe
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