Recall Z-2280-2019— Codman & Shurtleff Inc

Name: FDA recall Z-2280-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-16

Class II · Terminated

Class II FDA medical device recall by Codman & Shurtleff Inc, initiated 2019-05-16, terminated 2020-06-04. It names one FDA 510(k) clearance: K171862. Product: GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).. Reason: Incorrect coil length on the label.

Recalling firm: Codman & Shurtleff Inc
Classification: Class II
Status: Terminated
Initiated: 2019-05-16
Terminated: 2020-06-04
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K171862 — GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.·cleared 2017-09-25

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

GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).

Reason for recall

Incorrect coil length on the label

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