Bio-Detek Recalls ZOLL Pro-padz Liquid Gel Radiolucent Electrodes
Bio-Detek, Inc. is recalling ZOLL Pro-padz Liquid Gel Radiolucent electrodes because some may be assembled incorrectly, preventing the delivery of defibrillation or pacing therapy.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a defect that prevents the delivery of life-saving defibrillation or pacing therapy, which constitutes a significant risk of injury.
Plain-English summary
Bio-Detek, Inc. is recalling ZOLL Pro-padz Liquid Gel Radiolucent electrodes, part numbers 8900-2105-01 (12/case) and 8900-2106-01 (single). The recall involves 1,789 units from lots 1719, 1719A, and 1819.
The recall was initiated because some of the electrodes may have been assembled incorrectly. This defect may prevent the delivery of defibrillation or pacing therapy.
The affected products were distributed to accounts in Arizona, California, Colorado, Connecticut, Florida, Louisiana, Minnesota, Nevada, Ohio, Pennsylvania, Tennessee, Utah, and Wyoming. International distribution occurred in Canada, Germany, France, and Italy. Users should stop using the affected electrodes and contact Bio-Detek, Inc. for further instructions.
The recalled product
- Product
- ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
- Manufacturer
- Bio-Detek, Inc.
- Affected units
- 1,789
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)
- Lots 1719
- 1719A
- and 1819
Distribution
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