Recall of Boston Scientific Tracheobronchial Stents Due to Sterilization Labeling Error
SPS Sterilization, Inc. is recalling two Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stents because the expiration date on the labeling 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, and the source text explicitly states that the hazard is a labeling error regarding shelf life without any reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
SPS Sterilization, Inc. is recalling two units of the Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, which were resterilized. The recall is being conducted because the expiration date printed on the device labeling exceeds the actual validated shelf life. This discrepancy occurred because the sterilization process used did not have adequate support for the extended shelf life.
The affected devices are identified by Code Number 40512-R, Lot Number 17984215, and Serial Numbers 21408032017-14 and 21408032017-15. These units were distributed in the United States to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia.
Healthcare providers and facilities that have received these specific units should stop using them and contact SPS Sterilization, Inc. for instructions on return or disposal. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, 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 40512-R
- Lot Number 17984215
- Serial Number 21408032017-14
- 21408032017-15
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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