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.
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 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.
See all 15 products in this recall →Related recalls
Same manufacturer · SPS Sterilization, Inc
See all →- ModerateSPS Sterilization Recalls Boston Scientific Wallstent Tracheobronchial Stents
FDA (Devices) · 2018-09-19
- ModerateSPS Sterilization Recalls Resterilized Aortic Perfusion Cannulas Due to Shelf Life Labeling
FDA (Devices) · 2018-09-19
- ModerateSPS Sterilization Recalls Boston Scientific Wallstent Due to Expiration Date Error
FDA (Devices) · 2018-09-19
- ModerateSPS Sterilization Recalls Resterilized Boston Scientific Wallstent Enteral Endoprosthesis
FDA (Devices) · 2018-09-19
- ModerateSPS Sterilization Recalls Boston Scientific Wallstent RP Endoprosthesis Due to Labeling Error
FDA (Devices) · 2018-09-19
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighEdwards Lifesciences Recalls Duraflo Coated Femoral Cannula Due to Sealing Defect
FDA (Devices) · 2013-04-24
- HighEdwards Lifesciences Recalls Fem-Flex Femoral Arterial Cannulas Due to Cracks
FDA (Devices) · 2013-11-13
- ModerateEdwards Thin-Flex Venous Cannula Recalled for Incorrect Connector Size Labeling
FDA (Devices) · 2015-12-16
- HighEdwards Lifesciences Recalls Fem-Flex II Pediatric Femoral Arterial Cannulas
FDA (Devices) · 2015-04-08
- HighSNS Disposable Urethral Catheter Electrode Recalled for Sterilization Process Deviations
FDA (Devices) · 2021-07-07
- SevereEdwards Lifesciences Recalls QuickDraw Venous Cannulas Due to Connector Separation Risk
FDA (Devices) · 2020-01-22