SPS Sterilization Recalls Resterilized Boston Scientific Wallstent RP Endoprosthesis
SPS Sterilization is recalling two units of resterilized Boston Scientific Wallstent RP Endoprosthesis because the labeling expiration date 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 is a labeling error regarding shelf life validation, which falls under the rubric for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
SPS Sterilization, Inc. is recalling two units of the Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent (8MM X 80MM | 75CM). The specific units are identified by Code Number 71130-R, Lot Number 17401915, and Serial Numbers 21408032017-01 and 21408032017-02.
The recall was initiated because the expiration date on the device labeling exceeds the actual validated shelf life. The sterilization process used by the firm 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. Healthcare facilities and distributors should stop using the affected units and contact SPS Sterilization, Inc. for instructions on return or disposal.
The recalled product
- Product
- Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.
- Manufacturer
- SPS Sterilization, Inc
- Category
- Medical Device — Endoprosthesis
- Hazard
- 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 71130-R
- Lot Number 17401915
- Serial Number 21408032017-01
- 21408032017-02
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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