Recall Z-2529-2017— Creganna Medical Devices

Name: FDA recall Z-2529-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-22

Class II · Terminated

Class II FDA medical device recall by Creganna Medical Devices, initiated 2017-05-22, terminated 2018-05-29. It names one FDA 510(k) clearance: K131079. Product: Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200. Reason: Lack of sterility assurance..

Recalling firm: Creganna Medical Devices
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Terminated: 2018-05-29
Firm location: Galway, N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K131079 — CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRICCreganna Medical Devices·cleared 2013-08-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200

Reason for recall

Lack of sterility assurance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.