Zoll Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns
Bio-Detek is recalling 237 cases of Zoll Pro-padz Sterile Multi-Function Electrodes because product sterility is not assured. The affected lots were distributed worldwide.
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. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bio-Detek, Inc. is recalling 237 cases (6 units per case) of Zoll Pro-padz Sterile Multi-Function Electrodes (MFE), Part Number 8900-4012. The recall was initiated because product sterility is not assured for these devices.
The affected lots are 1614, 1814, and 1914. These electrodes are used in connection with ZOLL Defibrillators for adult patients for defibrillation, cardioversion, external non-invasive pacing, and monitoring. They are intended for use in a sterile environment by trained medical professionals.
The affected units were distributed worldwide, including the United States, Australia, Canada, Belgium, France, and Germany. Healthcare facilities and distributors should stop using the affected lots and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per
- 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 (3)
- Lot Numbers: 1614
- 1814
- 1914
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
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- HighZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues
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