SPS Sterilization Recalls Edwards Femoral Venous Cannula Due to Shelf Life 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.
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: The recall is classified as FDA Class II and involves a labeling error regarding shelf life without reported illnesses or injuries, 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, 18FR, resterilized. The recall is due to a labeling error where the expiration date on the device exceeds its actual validated shelf life. This occurred because the sterilization process used did not have adequate support for the extended shelf life.
The affected unit has Code Number VFEM018-R, Lot Number 59740463, and Serial Number 16704192017-01. The product 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.
The recalled product
- Product
- Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
- Manufacturer
- SPS Sterilization, Inc
- Category
- Medical Device — Vascular Access
- 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 VFEM018-R
- Lot Number 59740463
- Serial Number 16704192017-01
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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