FDA Medical Device Recalls (openFDA)
Creganna Medical Devices: Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
- Recall number
- Z-2532-2017
- Recalling firm
- Creganna Medical Devices
- Product
- Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
- Status
- Terminated
- Initiated
- 2017-05-22
- Posted
- not on file
- Terminated
- 2018-05-29
- Reason
- Lack of sterility assurance.
- Root cause
- Packaging
- Action
- The firm notified their sole consignee by email on 05/22/2017 requesting all lots of product be recalled.
- Quantity
- 50 units
- Distribution
- Distributed in MA.
- Lot, serial or model codes
- Lot # 384797
- 510(k) numbers
- ["K131079"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3004193842
- Firm city
- Galway
- Firm state
- not on file
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28