Recall Z-1998-2019— Terumo Medical Corporation

Name: FDA recall Z-1998-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-08

Class II · Terminated

Class II FDA medical device recall by Terumo Medical Corporation, initiated 2019-02-08, terminated 2020-05-08. It names one FDA 510(k) clearance: K121607. Product: Terumo Sur-vet Needle, 20G x 1", Product Code 100204. Reason: There is a potential for a loss of package integrity that may compromise the sterility of the product..

Recalling firm: Terumo Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-02-08
Terminated: 2020-05-08
Firm location: Elkton, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K121607 — TERUMO(R) NEEDLETerumo (Philippines) Corporation·cleared 2012-11-08

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

Terumo Sur-vet Needle, 20G x 1", Product Code 100204

Reason for recall

There is a potential for a loss of package integrity that may compromise the sterility of the product.

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