SPS Sterilization Recalls Venture Rx Catheters Due to Shelf Life Labeling Error
SPS Sterilization is recalling 3 resterilized Venture Rx Catheters 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 describes a labeling error regarding shelf life without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
SPS Sterilization, Inc. is recalling 3 units of the Vascular Solutions Venture Rx Catheter, 6F, resterilized. The recall is due to a labeling error where the expiration date on the device exceeds its actual validated shelf life. This occurred because the sterilization process used did not have adequate support for the extended shelf life.
The affected units were distributed in the United States to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia. The specific units are identified by Code Number 5820-R, Lot Number 570183 (Serial Number 99804132016-07), and Lot Number 583022 (Serial Numbers 17304202017-07 and 17304202017-08).
Healthcare providers and consumers should check their inventory for these specific lot and serial numbers. If found, the devices should be removed from use and returned to SPS Sterilization, Inc. according to the firm's instructions.
The recalled product
- Product
- Vascular Solutions Venture Rx Catheter, 6F, resterilized.
- Manufacturer
- SPS Sterilization, Inc
- Category
- Medical Device — Catheter
- Affected units
- 3
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 (4)
- Code Number 5820-R
- Lot Number 570183 (Serial Number 99804132016-07)
- Lot Number 583022 (Serial Number 17304202017-07
- 17304202017-08)
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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