SPS Sterilization Recalls Resterilized Edwards Arterial Perfusion Cannula
SPS Sterilization is recalling one resterilized Edwards Lifesciences Optisite Arterial Perfusion Cannula because its expiration date 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: This is a Class II recall involving a labeling error where the expiration date exceeds the validated shelf life. No illnesses or injuries are reported, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
SPS Sterilization, Inc. is recalling one unit of the Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, that was resterilized by the company. The specific unit is identified by Code Number OPTI22-R, Lot Number 59637295, and Serial Number 16502032017-01.
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 device was distributed in the United States to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia. The FDA has classified this as a Class II recall. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.
- Manufacturer
- SPS Sterilization, Inc
- Category
- Medical Device — Cardiovascular
- 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 OPTI22-R
- Lot Number 59637295
- Serial Number 16502032017-01
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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