SPS Sterilization Recalls Edwards Venous Drainage Cannulas Due to Labeling Error
SPS Sterilization is recalling five units of Edwards Lifesciences 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, and the source text identifies a labeling error regarding shelf life without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
SPS Sterilization, Inc. is recalling five units of Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannulas, 34F (11.3MM) X 40CM (16"), resterilized. The recall was initiated because the expiration date on the device labeling exceeds its actual validated shelf life, as the sterilization process used does not have adequate support for the extended shelf life.
The affected units are identified by Code Number TF034L-R, Lot Number 59739865, and Serial Numbers 18304192017-12 through 18304192017-16. These 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 devices and contact SPS Sterilization, Inc. for further instructions or a replacement.
The recalled product
- Product
- Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
- Manufacturer
- SPS Sterilization, Inc
- 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 TF034L-R
- Lot Number 59739865
- Serial Numbers 18304192017-12
- 18304192017-13
- 18304192017-14
- 18304192017-15
- 18304192017-16
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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