Medical device recall: EASYGRIP FLO-41 barcode expiration date discrepancy
Baxter Healthcare Corporation is recalling 4,752 units of EASYGRIP FLO-41 hemostatic delivery devices due to a discrepancy between the expiration date encoded in the 2D barcode and the human-readable date on the product.
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: FDA Class II device recall with no reported illnesses or injuries. The discrepancy between barcode-encoded and human-readable expiration dates is a labeling error without reported harm or evidence of pathogenic contamination.
Plain-English summary
Baxter Healthcare Corporation is recalling 4,752 units of EASYGRIP FLO-41 US, a hemostatic agent delivery device used during surgical procedures. The recall affects products distributed across the United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.
The reason for the recall is a discrepancy in the expiration date encoded into the 2D barcode compared to the human-readable expiration date printed on the product. The human-readable date is the correct expiration date.
The recalled lot numbers are: 0000266641, 0000325839, 0000362640, and 0000380266 (product code ADS201897). Healthcare facilities should refer to the human-readable expiration date on the product when determining shelf life and usability. Organizations with affected inventory should contact Baxter Healthcare Corporation for instructions.
The recalled product
- Product
- EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device
- Affected units
- 4,752
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 (4)
- Product Code: ADS201897. Lot Numbers: 0000266641
- 0000325839
- 0000362640
- 0000380266.
Distribution
Distribution scope not specified by the agency.
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