Codman Cranial Access Kits Recall: Incorrect Expiration Dates on Labels
Integra LifeSciences is recalling Codman Cranial Access Kits due to incorrect extended expiration dates printed on outer box labels. Using expired kits may result in pain, infection, or adverse tissue reaction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall with no reported illnesses or injuries. However, the potential consequences of using expired surgical equipment in craniotomy procedures—including infection and adverse tissue reaction—are serious. The recall is driven by labeling errors affecting verification of proper expiration dates.
Plain-English summary
Integra LifeSciences Corp. is recalling Codman Cranial Access Kits (Part Number 826616) due to incorrect extended expiration dates printed on the outer box labels. The affected kits have lot numbers 20DDA264 and 21HDA861. These kits are used during craniotomy procedures for placement of intracranial pressure (ICP) monitoring devices and cerebrospinal fluid (CSF) drainage.
The outer box labels display expiration dates that do not match the correct expiration dates of the kits. If a kit is used after its actual expiration date has passed, there is potential for pain, infection, or adverse tissue reaction.
The recall affects 1,160 kits distributed worldwide, including the United States and Hong Kong.
The recalled product
- Product
- 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
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- expiration-error
- infection
- adverse-tissue-reaction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers: 20DDA264
- 21HDA861 UDI# 10381780520382
Distribution
Distributed nationwide across the United States.
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