Boston Scientific Steerable Sheath Recalled for Lack of Sterility Assurance
Creganna Medical Devices is recalling 100 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 3/5 (High).
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 medical device with a lack of sterility assurance, which poses a risk of harm (infection) even though no specific injuries are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Creganna Medical Devices is recalling 100 units of the Boston Scientific Zurpaz MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400. The recall is being conducted because the product lacks sterility assurance.
The affected units are identified by Lot # 363848. The source text indicates that these products were distributed in Massachusetts.
Healthcare providers and consumers should stop using the recalled products immediately and contact Creganna Medical Devices for further instructions.
The recalled product
- Product
- Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
- Manufacturer
- Creganna Medical Devices
- Hazard
- Affected units
- 100
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 (1)
- Lot # 363848
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.
See all 4 products in this recall →Related recalls
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