SPS Sterilization Recalls Boston Scientific Wallstent RP Endoprosthesis Due to Labeling Error
SPS Sterilization, Inc. is recalling three Boston Scientific Wallstent RP Endoprosthesis tracheobronchial 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, which typically corresponds to a moderate severity score. The hazard is a labeling error regarding shelf life, which is a documentation issue rather than a direct physical defect or contamination.
Plain-English summary
SPS Sterilization, Inc. is recalling three units of the Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM. 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 its 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. This is a Class II recall, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected units are identified by Code Number 71139-R; Lot Numbers 17752073 and 17422520; and Serial Numbers 21408032017-03, 21408032017-04, and 21408032017-05. Healthcare providers and facilities that have received these specific stents should stop using them and contact SPS Sterilization, Inc. for instructions on return or disposal.
The recalled product
- Product
- Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.
- Manufacturer
- SPS Sterilization, Inc
- Hazard
- Affected units
- 3
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 (7)
- Code Number 71139-R
- Lot Numbers 17752073
- 17752073
- 17422520
- Serial Numbers 21408032017-03
- 21408032017-04
- 21408032017-05
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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