Z-2531-2017Class II

Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No...

Name: Z-2531-2017 Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No...
Creator: Creganna Medical Devices
Published: 2017-05-22
License: https://open.fda.gov/license/

Creganna Medical Ireland Limited / initiated 2017-05-22 / Terminated / root cause: packaging

FDA source

Creganna Medical Devices began a recall of Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400 on 2017-05-22. FDA classified it as Class II and gives the reason as "Lack of sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2531-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Posted: 2017-06-14
Terminated: 2018-05-29
Recalling firm: Creganna Medical Ireland Limited
Product: Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
Product code: DYB Introducer, Catheter
Reason for recall: Lack of sterility assurance.
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm notified their sole consignee by email on 05/22/2017 requesting all lots of product be recalled.
Quantity in commerce: 100 uniits
Distribution: Distributed in MA.
Product codes and lots: Lot # 363848

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2531-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2529-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-13
Z-2530-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-13
Z-2531-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-13
Z-2532-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-13

Product code DYB

K131079Class IICreganna-Tactx Steerable Sheath Set SymmetricCreganna Medical Devices / cleared 2013-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)