SPS Sterilization Recalls Boston Scientific Wallstent Tracheobronchial Stents
SPS Sterilization is recalling two Boston Scientific Wallstent tracheobronchial stents because the expiration date on the labeling exceeds the validated shelf life of the sterilization process.
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. The hazard is a labeling error regarding shelf life validation, which is a moderate risk but does not involve immediate physical defects or reported injuries.
Plain-English summary
SPS Sterilization, Inc. is recalling two units of the Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent (22MM X 45MM | 75CM L). The devices were resterilized by SPS Sterilization, Inc. and distributed in the United States to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia.
The recall was initiated because the expiration date on the device labeling exceeds the 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 40451-R, Lot Number 18098774, and Serial Numbers 21408032017-12 and 21408032017-13. Healthcare facilities and distributors should stop using these specific units and contact SPS Sterilization, Inc. for further instructions.
The recalled product
- Product
- Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 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 40451-R
- Lot Number 18098774
- Serial Number 21408032017-12
- 21408032017-13
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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