Boston Scientific Steerable Sheath Recalled for Sterility Assurance Issues
Creganna Medical Devices is recalling 85 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as sterility assurance failures in invasive medical devices.
Plain-English summary
Creganna Medical Devices is recalling 85 units of the Boston Scientific Zurpaz MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm). The recall is being conducted because of a lack of sterility assurance for the affected medical devices.
The affected products are identified by Lot # 364951 and 385149. These units were distributed in Massachusetts. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and facilities that have received these specific sheaths should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200
- Manufacturer
- Creganna Medical Devices
- Affected units
- 85
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 # 364951
- 385149
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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