The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0817-2022·Announced 2022-03-30

Codman Cranial Access Kits Recalled Due to Incorrect Expiration Dates on Labels

Integra LifeSciences is recalling 1,161 Codman Cranial Access Kits due to incorrect expiration dates on the outer box labels. Using the product past its correct expiration date may cause pain, infection, or adverse tissue reaction.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 recall of a medical device used in high-risk intracranial procedures. No hospitalizations or injuries have been reported, and the potential harm is contingent on use beyond the actual expiration date. Per the rubric, risk-of-harm products without reported injuries are scored as High (3).

Plain-English summary

Integra LifeSciences Corp. is recalling 1,161 Codman Cranial Access Kits (Product Number 826614) due to incorrect extended expiration dates printed on the outer box labels only. The affected lot numbers are 20LDC222 and 21HDC461.

If a kit is used after its actual expiration date, the sterility and safety of the device cannot be assured, creating a potential risk of pain, infection, or adverse tissue reaction. These kits are designed for use during craniotomy procedures for intracranial pressure monitoring and cerebrospinal fluid drainage.

The kits were distributed nationwide in the United States and to Hong Kong. Healthcare facilities should identify affected kits using the lot numbers and verify the correct expiration date before use.

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. Product umber: 826614
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Neurosurgical
Hazard
Affected units
1,161

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: 20LDC222
  • 21HDC461 UDI# 10381780520375

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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