International Medical Devices Database

Manufacturer Address
Bio-Detek, Inc., 525 Narragansett Park Dr, Pawtucket RI 02861-4323
Source
USFDA
11 Events

8 devices in the database

Device Recall Zoll

Model / Serial
Lot Numbers: 3103, 3203, 3303, 3403, 3503, 3603, 3703, 3803, 3903, 4003, 4103, 4203, 4303
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode || part Number: 8900-2065

Device Recall Zoll pedi.padz Reduced Energy MultiFunction Electrodes (MFE)

Model / Serial
Lot Numbers 0510 thru 4511
Product Classification
Cardiovascular Devices
Distribution
Worldwide Distribution -- US and Canada.
Product Description
Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) || Part number: 8900-0401 || Used in connection with Zoll M Series and E series Defibrillators specifically for pediatric patients.

Device Recall Medsolutions4U MultiFunction Electrodes

Model / Serial
Lot #0413 Expiration Date: 2015-01-26
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution in Germany and Slovenia.
Product Description
Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring || Part Number: 2033

Device Recall Zoll Medical Corp

Model / Serial
Lot Number: 2314
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
Product Description
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with || 10-ft (3 m) leadwires || Part number: 8900-4052 || These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

Device Recall Zoll MultiFunction Electrode

Model / Serial
Lot #'s : 2108 & 2208
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
MA
Product Description
ZOLL OneStep Multi-Function Electrode; Adult Complete || Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring.

3 more

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Bio-Detek, Inc.