Recall Z-0065-2020— Stryker Neurovascular

Name: FDA recall Z-0065-2020
Creator: U.S. Food and Drug Administration
Published: 2018-11-13

Class II · Terminated

Class II FDA medical device recall by Stryker Neurovascular, initiated 2018-11-13, terminated 2020-08-03. It names 2 FDA 510(k) clearances: K112404, K010954. Product: Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771. Reason: Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging.

Recalling firm: Stryker Neurovascular
Classification: Class II
Status: Terminated
Initiated: 2018-11-13
Terminated: 2020-08-03
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K112404 — CONCENTRIC BALLOON GUIDE CATHETERConcentric Medical, Inc.·cleared 2012-03-15
K010954 — CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031Concentric Medical, Inc.·cleared 2001-10-09

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

Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771

Reason for recall

Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging

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