Drugs & medicalClass I

Integra LifeSciences Corp. recalls CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.

Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by…

Read the official notice →
Date
2022-08-03
Country
United States
Brand
Integra LifeSciences
Product
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Classification
Class I
Units
Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

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  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Integra LifeSciences recalls

  1. 2023-12-13
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    Integra LifeSciences Corp. recalls Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040

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  4. 2023-05-31
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    Integra LifeSciences Corp. recalls Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device…

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  6. 2023-01-18
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  8. 2022-04-20
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    Integra LifeSciences Corp. recalls Integra Universal Flexible Arm part number REF 1362275

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    FDA · DeviceIntegra LifeSciences Corp.US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TXOfficial notice →
  10. 2022-03-30
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    Integra LifeSciences Corp. recalls Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device…

    Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur

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Other drugs & medical recalls in the United States

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