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[Recalled] Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Part Number: 826616 — Incorrect extended expir

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductCodman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Part Number: 826616
Brand / manufacturerIntegra LifeSciences Corp.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0818-2022
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date21 January 2022
EAN / barcode10381780520382

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Integra LifeSciences Corp.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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