ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Concerns
Bio-Detek is recalling 198 cases of 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 involves a sterile medical device where sterility is not assured, creating a risk of infection. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Bio-Detek, Inc. is recalling 198 cases of ZOLL Pro-padz Sterile Adult Multi-Function Electrodes, part number 8900-4012, lot number 2314. These disposable, single-use electrodes are used with ZOLL Defibrillators for adult patients to provide defibrillation, cardioversion, external non-invasive pacing, and monitoring. The devices are intended for use in a sterile environment by trained medical professionals.
The recall was initiated because the sterility of the device is not assured. The source text does not specify the root cause of the sterility failure, nor does it report any illnesses, injuries, or deaths associated with the use of these products.
The affected units were distributed nationwide in the United States and internationally to Australia, Canada, and Germany. Consumers and healthcare facilities should stop using the recalled lot and contact Bio-Detek, Inc. for instructions on return or replacement.
The recalled product
- Product
- ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ Nat
- Manufacturer
- Bio-Detek, Inc.
- Affected units
- 198
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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- HighZOLL Pro-padz Sterile Adult Electrodes Recalled Due to Sterility Concerns
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- HighZOLL Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns
FDA (Devices) · 2014-10-15
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