ZOLL Pro-padz Sterile Adult Electrodes Recalled Due to Sterility Concerns
Bio-Detek is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because product sterility is not assured. The recall affects 193 cases 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 is classified as FDA Class II. The hazard is a risk-of-harm product (sterility not assured) where injury has not yet been reported, fitting the criteria for a High severity score.
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 is being conducted because product sterility is not assured. These electrodes are used in connection with ZOLL Defibrillators for adult patients and are intended for use in a sterile environment by trained medical professionals.
The recall involves 193 cases (6 per case) of the affected product. The specific lot numbers included in this recall are 1614, 1914, and 2114. The product was distributed worldwide, including the United States, Australia, Canada, Belgium, France, and Germany.
Healthcare facilities and consumers should stop using the affected electrodes and contact Bio-Detek, Inc. for further instructions or a refund. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radi
- 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
- 1914
- 2114
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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