VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
Civco Medical Instruments Co.
Class I - Dangerous
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
Civco Medical Instruments Co.
Class I - Dangerous
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Class I - Dangerous
Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.
VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
Civco Medical Instruments Co.
Class I - Dangerous
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Class I - Dangerous
The kit contains a non-sterile needle.
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Cardiovascular Systems
Class I - Dangerous
Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Cardinal Health
Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Cardinal Health
Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Cardinal Health
Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Cardinal Health
Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
Cardinal Health
Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
Class I - Dangerous
Product is not approved for use in the EU and should not have been distributed in the EU.
SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
Cardinal Health
Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
Cardinal Health
Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
Incorrect expiration date on its package labeling (shipper box and inner carton label).