Baxter Neurosurgical Headrest Recalled Due to Defective Adhesive
Baxter Healthcare is recalling C-Flex Polar Head Positioning Device neurosurgical headrests because adhesive on fasteners may not cure correctly, potentially compromising mechanical integrity and holding force.
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 risk-of-harm medical device where no injuries have been reported. The neurosurgical headrest could fail mechanically due to adhesive defect, creating potential for serious patient harm during surgical procedures. FDA Class II classification is consistent with this severity level.
Plain-English summary
Baxter Healthcare Corporation is recalling the C-Flex Polar Head Positioning Device neurosurgical headrest because adhesive applied to screws and bolts may not cure correctly during manufacturing. This defect could result in loss of holding force and reduced mechanical integrity of the device.
The recall affects 2 units with lot numbers 122190000182 and 122190001101 (UDI/DI 00615521002701). The devices were distributed in Michigan, BA, Wisconsin, Washington, Texas, and internationally to Germany, Japan, South Korea, Sweden, and South Africa.
Facilities that have received affected units should stop using them and contact Baxter Healthcare Corporation for instructions on return or replacement.
The recalled product
- Product
- C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
- 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 (3)
- UDI/DI 00615521002701
- Lot Numbers: 122190000182
- 122190001101
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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