Integra LifeSciences recalls Codman Cranial Access Kits with incorrect expiration dates on outer box labels. Using past expiration date may cause pain, infection, or adverse tissue reactions. Affected kits have specific part and lot numbers.
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
Integra LifeSc: Codman Cranial Access Kits are recalled because their outer box labels show incorrect expiration dates. Using these kits past the correct expiration date could lead to pain, infection, or adverse tissue reactions.
The kits have incorrect expiration dates on the outer box labels. If used past the correct expiration date, there is a potential for pain, infection, or adverse tissue reactions to occur.
Healthcare professionals who use these kits for craniotomy procedures are most at risk. Patients receiving these kits during surgery may also be affected if the expiration date is incorrect.
Check the outer box label for expiration dates. Affected kits have part number 826616 and lot numbers 20DDA264 or 21HDA861.
Verify the expiration date on the outer box label. If it's past the correct expiration date, stop using the kit.
The recall record does not specify the correct expiration date.
The recall record only mentions Codman Cranial Access Kits with part number 826616 and lot numbers 20DDA264 or 21HDA861.
Check the outer box label for expiration dates. Affected kits have part number 826616 and lot numbers 20DDA264 or 21HDA861.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0818-2022 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0818-2022 from Integra LifeSciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
