Getinge Hemashield Cardiovascular Fabric Recalled for Packaging Mislabeling
Getinge US Sales LLC is recalling Hemashield Knitted Double Velour Cardiovascular Fabric because the packaging label lists a different product size than the actual item inside.
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 and involves a labeling error where the packaging size does not match the product size. This fits the rubric for moderate severity, as it is a labeling error without reported injuries or high-risk pathogens.
Plain-English summary
Getinge US Sales LLC is recalling one unit of Hemashield Knitted Double Velour Cardiovascular Fabric. The recall was initiated due to a probable mislabeling issue where the product packaging label references a size of 2.5 cm (width) x 7.6 cm (length), while the actual product inside the box measures 2.5 cm (width) x 15 cm (length).
The affected product is identified by UDI code 00384401017899, Catalog number M002000195140, Lot number 16M21, and Serial number 1092238229. The distribution pattern is listed as FL.
This recall is classified as Class II by the FDA. Consumers and healthcare providers should check their inventory for the specific serial and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or an authorized distributor for credit or replacement.
The recalled product
- Product
- HEMASHIELD Knitted Double Velour Cardiovascular Fabric
- Manufacturer
- GETINGE US SALES LLC
- Hazard
- Affected units
- 1
Distribution
Distributed in 1 state:
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