Medical Monofilament Testing Devices Recalled for Temperature Excursion
Mckesson Medical-Surgical is recalling monofilament sensory testing devices (13 units) due to temperature excursions during June-August 2021. Heat exposure may have compromised device effectiveness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class III medical device recall with a theoretical hazard (reduced effectiveness from heat exposure). No illnesses or injuries have been reported. The recall is precautionary in nature.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling the Medical Monofilament Test device (Model Number AM140), used for sensory testing of foot sensitivity. Thirteen units are affected.
The devices experienced facility temperature excursions between June and August 2021 prior to delivery. Exposure to higher temperatures may have compromised the product's effectiveness as a diagnostic testing tool.
The affected devices have nationwide U.S. distribution. All lots received between June 1, 2021 and September 30, 2021 are included in the recall.
The recalled product
- Product
- Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- Affected units
- 13
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 (1)
- Unknown
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 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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