SPS Sterilization Recalls Resterilized Aortic Perfusion Cannulas Due to Shelf Life Labeling
SPS Sterilization, Inc. is recalling 10 units of resterilized Edwards Lifesciences Aortic Perfusion Cannulas because the expiration date on the labeling 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, which corresponds to a Moderate severity score. The hazard is a labeling error regarding shelf life, and the source text does not report any illnesses or injuries.
Plain-English summary
SPS Sterilization, Inc. is recalling 10 units of Edwards Lifesciences Aortic Perfusion Cannulas, 24F x 30CM, that were resterilized by the firm. The recall involves Code Number AAO24TFA-R, Lot Number 59736014, and Serial Numbers 16504192017-01 through 16504192017-10.
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 devices were distributed in the United States to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia. Healthcare facilities and consumers should stop using these specific units and contact SPS Sterilization, Inc. for further instructions.
The recalled product
- Product
- Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.
- Manufacturer
- SPS Sterilization, Inc
- Hazard
- Affected units
- 10
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 (12)
- Code Number AAO24TFA-R
- Lot Number 59736014
- Serial Numbers 16504192017-01
- 16504192017-02
- 16504192017-03
- 16504192017-04
- 16504192017-05
- 16504192017-06
- 16504192017-07
- 16504192017-08
- 16504192017-09
- 16504192017-10
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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