Edwards Lifesciences Recalls FloTrac Sensor Due to Packaging Error
Edwards Lifesciences is recalling 35 units of the FloTrac Sensor Model MHD85 because incorrect packaging configuration prevents validation of the product's sterility.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, but the source text explicitly states there is no evidence to validate sterility rather than reporting confirmed contamination or injuries. This fits the rubric for moderate severity involving potential risk without reported harm.
Plain-English summary
Edwards Lifesciences, LLC is recalling 35 units of the FloTrac Sensor Model MHD85. This sterile, single-use kit is designed to monitor pressures when attached to pressure monitoring catheters. The recall is due to a manufacturing non-conformance involving incorrect packaging configuration.
The specific defect involves the Instructions for Use (IFU) being placed on top of the Tyvek material instead of at the bottom of the box. According to the source text, there is no evidence available at this time to validate the sterility of the product in this incorrect packaging configuration.
The affected units were distributed nationwide, including in Missouri and Michigan. The product code is 595531157. Consumers and healthcare providers should check their inventory for this specific model and code and discontinue use if the packaging matches the described non-conformance.
The recalled product
- Product
- "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 35
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)
- 595531157
Distribution
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