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 Details may be shortened or out of date; the official notice is the authoritative source.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
What to do
- Check the product name, strength and lot number against the official notice.
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- 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
- 2023-12-13
US
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Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →US
Integra LifeSciences Corp. recalls Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of…
Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →- 2023-05-31
US
Integra LifeSciences Corp. recalls Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device…
Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay,…
- 2023-01-18
US
Integra LifeSciences Corp. recalls Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
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FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide distribution in the states of CA, CO,…Official notice →- 2022-04-20
US
Integra LifeSciences Corp. recalls Integra Universal Flexible Arm part number REF 1362275
Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.
FDA · DeviceIntegra LifeSciences Corp.US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TXOfficial notice →- 2022-03-30
US
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
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the country of Hong Kong.Official notice →
Other drugs & medical recalls in the United States
- 2022-08-03
US
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BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2)…
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Pfizer Inc. recalls Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a…
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US