Recall Z-0585-2020— Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Name: FDA recall Z-0585-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-24

Class II · Terminated

Class II FDA medical device recall by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., initiated 2019-09-24, terminated 2020-10-21. It names one FDA 510(k) clearance: K181208. Product: 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001. Reason: Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray..

Recalling firm: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-09-24
Terminated: 2020-10-21
Firm location: Dover, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K181208 — Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterVygon USA·cleared 2018-11-02

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

4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001

Reason for recall

Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.

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