Integra LifeSciences Corp. recalls Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Read the official notice →- Date
- 2024-05-29
- Country
- United States
- Brand
- Integra LifeSciences
- Product
- Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of CA, BE, CL.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Integra LifeSciences recalls
- 2024-07-17
US
Integra LifeSciences Corp. recalls AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
- 2024-07-03
US
Integra LifeSciences Corp. recalls CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration…
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
FDA · DeviceIntegra LifeSciences Corp.Nationwide Foreign: Argentina Australia Bangladesh Bangladesh Belgium Bolivia…Official notice →- 2024-06-19
US
Integra LifeSciences Corp. recalls CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally…
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
FDA · DeviceIntegra LifeSciences Corp.Worldwide - US Nationwide distribution in the state of TX and the countries of…Official notice →- 2024-03-06
US
Integra LifeSciences Corp. recalls Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the…
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Austria, Bahamas,…Official notice →- 2023-12-20
US
Integra LifeSciences Corp. recalls CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model…
Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to…
FDA · DeviceIntegra LifeSciences Corp.US distribution nationwide to the following states: AL AR AZ CA CO CT DC DE FL…Official notice →- 2023-12-13
US
Integra LifeSciences Corp. recalls Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
Other drugs & medical recalls in the United States
- 2024-05-29
US
Cadwell Industries Inc recalls Cascade IOMAX Cortical Module, REF: 190296-200
There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
FDA · DeviceCadwell Industries IncWorldwide - US Nationwide distribution in the state of MD and the countries of…Official notice →US
Ethicon, Inc. recalls SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Some applicator tips from these lots had open seals.
FDA · DeviceEthicon, Inc.US Nationwide distribution in the states of AR, CA, FL, GA, ID, IL, IN, KY,…Official notice →US
Merit Medical Systems, Inc. recalls Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the state of CA and the countries of…Official notice →US
Philips North America Llc recalls Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the…
US
Fresenius Medical Care Holdings, Inc. recalls Blood Pump Rotor, Model Number: F40015481 Rev A
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
US
Philips North America Llc recalls Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice →