ZOLL Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns
Bio-Detek is recalling ZOLL Pro-padz Sterile Multi-Function Electrodes because product sterility is not assured. The recall affects lots 1614 and 1814 distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 and involves a risk-of-harm product (sterile medical device) where sterility is not assured, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single, part number 8900-4013. The recall is being conducted because product sterility is not assured. These electrodes are used in connection with ZOLL Defibrillators for adult patients for defibrillation, cardioversion, external non-invasive pacing, and monitoring.
The affected product consists of 18 singles per package. The specific lot numbers involved in this recall are 1614 and 1814. The product was distributed worldwide, including the United States, Australia, Canada, Belgium, France, and Germany.
Consumers and healthcare facilities should stop using the affected lots and contact Bio-Detek, Inc. for further instructions or a return. The FDA has classified this recall as Class II.
The recalled product
- Product
- ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 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…
- Manufacturer
- Bio-Detek, Inc.
- Affected units
- 18
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 (2)
- Lot Numbers: 1614
- 1814
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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