Boston Scientific Steerable Sheath Recalled for Lack of Sterility Assurance
Creganna Medical Devices is recalling 150 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance. The devices were distributed in Massachusetts.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (lack of sterility assurance) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
Creganna Medical Devices is recalling 150 units of the Boston Scientific Zurpaz MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100. The recall is being conducted because of a lack of sterility assurance for the affected medical devices.
The affected units are identified by Lot # 383271 and 384264. These devices were distributed in Massachusetts. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for instructions on return or disposal. Patients who have had these devices implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
- Manufacturer
- Creganna Medical Devices
- Hazard
- Affected units
- 150
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 (2)
- Lot # 383271
- 384264
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Creganna Medical Devices 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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