C-Flex Polar Head Positnr-Device Only recall
C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
Why was C-Flex Polar Head Positnr-Device Only recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00615521002701, Lot Numbers: 122190000182, 122190001101
- Product
- C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 2 units
- Distribution
- MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
- Recall date
- November 9, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)