ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues
Bio-Detek is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a sterile medical device where sterility is not assured, posing a risk of infection or harm, but the source text does not report any specific illnesses, injuries, or fatalities.
Plain-English summary
Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, Part number 8900-4052. The recall involves 100 cases, containing 600 units, from Lot Number 2314. These disposable, single-use electrodes are used in connection with ZOLL Defibrillators for adult patients for defibrillation, cardioversion, external non-invasive pacing, and monitoring.
The recall was initiated because the sterility of the device is not assured. The products were processed through Gamma Radiation, but the recall indicates a failure to guarantee the sterile condition of the medical device.
The affected units were distributed worldwide, including nationwide in the USA and internationally to Australia, Canada, and Germany. Consumers and healthcare facilities should stop using the affected lot and contact Bio-Detek, Inc. for further instructions or a return.
The recalled product
- Product
- 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 indicati
- Manufacturer
- Bio-Detek, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 2314
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Bio-Detek, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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