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Integra LifeSciences Corp. Recall 93881

Description: Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.

Integra LifeSciences Corp. Recall 93881 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1196-2024
Event ID93881
Event DescriptionRef No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).
Quantity1324 units
Recall ReasonA defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Device Classification20240306
Device Code InfoUDI: 10381780263906 Lot Number Exp Date: 7249001 29-Jun-25 7253133 29-Jun-25 7253134 29-Jun-25 7253135 16-Jul-25 7253136 16-Jul-25 7275711 29-Jul-25 7300837 29-Jun-25
Center Classification Date20240228
Recall Initiation Date20240119
Recalling FirmIntegra LifeSciences Corp.
Initial Notification Letter
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