Product Safety Recalls

Product Recall Tracker

Integra LifeSciences Corp. Recall 89618

Description: 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

Integra LifeSciences Corp. Recall 89618 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0818-2022
Event ID89618
Event DescriptionCodman 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
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the country of Hong Kong.
Quantity1160 kits
Recall ReasonIncorrect 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
Device Classification20220330
Device Code InfoLot Numbers: 20DDA264, 21HDA861 UDI# 10381780520382
Center Classification Date20220322
Recall Initiation Date20220121
Recalling FirmIntegra LifeSciences Corp.
Initial Notification Letter
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.