SPS Sterilization Recalls Resterilized Venous Drainage Cannulas Due to Shelf Life Labeling
SPS Sterilization is recalling 10 units of resterilized 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 hazard is a labeling error regarding shelf life without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
SPS Sterilization, Inc. is recalling 10 units of Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannulas (38FRX40CM) that were resterilized by the company. The recall involves specific units identified by Code Number TF038L-R, Lot Number 59634935, and Serial Numbers 18302172017-01 through 18302172017-10.
The recall was initiated because the expiration date printed on the device labeling exceeds the actual validated shelf life. The sterilization process used by SPS Sterilization does not have adequate support to justify 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 who have these specific units should stop using them and contact SPS Sterilization for instructions on return or disposal.
The recalled product
- Product
- Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, 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 TF038L-R
- Lot Number 59634935
- Serial Numbers 18302172017-01
- 18302172017-02
- 18302172017-03
- 18302172017-04
- 18302172017-05
- 18302172017-06
- 18302172017-07
- 18302172017-08
- 18302172017-09
- 18302172017-10
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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