Cadwell Disposable Ground Electrodes Recalled Due to Temperature Exposure
Cadwell Disposable Ground Electrodes may have reduced effectiveness due to facility temperature excursions between June and August 2021. All units distributed nationwide received between June 1 and September 30, 2021 are affected.
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: This Class II medical device recall involves risk-of-harm due to potential reduction in product effectiveness from temperature exposure, with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Cadwell Disposable Ground Electrodes (Model 302288-000) manufactured by Mckesson Medical-Surgical Inc. are being recalled due to temperature excursions that occurred at the facility between June and August 2021. Exposure to higher temperatures prior to delivery may have impacted the product's effectiveness.
The recall affects all lots of these disposable grounding pads (1.25 X 1.75 inch dimensions) that were received between June 1, 2021 and September 30, 2021. These products were distributed nationwide in the United States. Affected units are identified by GTIN codes 20840067101395, 10840067101398, and 00840067101391.
The recalled product
- Product
- Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable Model Number: 302288-000
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 2
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)
- GTIN: 20840067101395
- 10840067101398
- 00840067101391
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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.
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