SPS Sterilization Recalls Resterilized Boston Scientific Wallstent Enteral Endoprosthesis
SPS Sterilization, Inc. is recalling two units of resterilized Boston Scientific Wallstent Enteral Endoprosthesis 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. The hazard involves a labeling error regarding shelf life and sterilization validation, which is a low-risk contamination or labeling issue without reported injuries, fitting the Moderate severity criteria.
Plain-English summary
SPS Sterilization, Inc. is recalling two units of the Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, that were resterilized by the firm. The recall involves specific units identified by Code Number 6559-R and Lot Numbers 17252887 and 17465176.
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, Inc. 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. Consumers and healthcare providers should stop using the affected devices and contact SPS Sterilization, Inc. for further instructions.
The recalled product
- Product
- Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
- Manufacturer
- SPS Sterilization, Inc
- Affected units
- 2
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 6559-R
- Lot Number 17252887 (Serial Number 16211282016-02)
- Lot Number 17465176 (Serial Numbers 97403172017-16
- 97403172017-40)
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.
See all 15 products in this recall →Related recalls
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