Boston Scientific Steerable Sheath Recalled for Sterility Assurance Issues
Creganna Medical Devices is recalling 50 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While the source text does not explicitly mention hospitalizations, a lack of sterility assurance in a medical device is a significant safety hazard that aligns with the Severe classification for Class II recalls.
Plain-English summary
Creganna Medical Devices is recalling 50 units of Boston Scientific Zurpaz MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300. The recall is being conducted because of a lack of sterility assurance for the affected medical devices.
The affected units are identified by Lot # 384797. These devices were distributed in Massachusetts. The source text does not provide specific dates of distribution or additional details regarding the extent of the distribution beyond the state of Massachusetts.
Healthcare providers and facilities that have received these devices should stop using them immediately. Patients who have had these devices implanted should contact their healthcare provider for further evaluation and guidance.
The recalled product
- Product
- Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
- Manufacturer
- Creganna Medical Devices
- Hazard
- Affected units
- 50
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 # 384797
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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