SPS Sterilization Recalls Boston Scientific Wallstent Due to Expiration Date Error
SPS Sterilization is recalling two Boston Scientific Wallstent devices because the expiration date on the label exceeds the validated shelf life.
What this means for you
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, which typically corresponds to a moderate severity score. The issue is a labeling error regarding shelf life validation rather than a direct contamination or structural defect causing immediate harm.
Plain-English summary
SPS Sterilization, Inc. is recalling two units of the Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L. The devices were resterilized by SPS Sterilization.
The recall was initiated because the expiration date on the device labeling exceeds its actual validated shelf life. The sterilization process used does not have adequate support for the extended shelf life indicated on the label.
The affected units are identified by Code Number 40213-R, Lot Number 18030192, and Serial Numbers 21408032017-10 and 21408032017-11. These devices were distributed in the United States to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia. Healthcare facilities and patients who have received these specific units should contact SPS Sterilization for further instructions.
The recalled product
- Product
- Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
- Manufacturer
- SPS Sterilization, Inc
- Category
- Medical Device — Stent
- 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 40213-R
- Lot Number 18030192
- Serial Number 21408032017-10
- 21408032017-11
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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