SPS Sterilization Recalls Avid Venous Drainage Cannulas Due to Shelf Life Labeling
SPS Sterilization is recalling 5 units of Avid Dual Stage Venous Drainage Cannulas 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, but the source text explicitly states no illnesses or injuries have been reported and the hazard is a labeling error regarding shelf life, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
SPS Sterilization, Inc. is recalling 5 units of the Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized. The recall involves Code Number TF293702-R, Lot Number 59655659, and Serial Numbers 18304192017-02 through 18304192017-06.
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. This is an FDA Class II recall. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
- Manufacturer
- SPS Sterilization, Inc
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 5
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 (7)
- Code Number TF293702-R
- Lot Number 59655659
- Serial Numbers 18304192017-02
- 18304192017-03
- 18304192017-04
- 18304192017-05
- 18304192017-06
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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