SPS Sterilization Recalls Edwards Femoral Venous Cannula Due to Shelf Life Labeling Error
SPS Sterilization is recalling one unit of an Edwards Lifesciences Femoral Venous Cannula because the expiration date on the label exceeds the validated shelf life.
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. The hazard is a labeling error regarding shelf life without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
SPS Sterilization, Inc. is recalling one unit of the Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized. The recall was initiated because the expiration date on the device labeling exceeds its actual validated shelf life. The sterilization process used does not have adequate support for the extended shelf life indicated on the label.
The affected device is identified by Code Number VFEM020-R, Lot Number 59691447, and Serial Number 16704032017-01. The unit was distributed in the United States to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia.
Consumers and healthcare facilities should stop using the affected device and contact SPS Sterilization, Inc. for further instructions or a return.
The recalled product
- Product
- Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.
- Manufacturer
- SPS Sterilization, Inc
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 1
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)
- Code Number VFEM020-R
- Lot Number 59691447
- Serial Number 16704032017-01
Distribution
Part of a larger recall action
This product is one of 15 recalled by SPS Sterilization, Inc 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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