Recall Z-1422-2018— Carefusion 2200 Inc

Name: FDA recall Z-1422-2018
Creator: U.S. Food and Drug Administration
Published: 2017-02-23

Class II · Terminated

Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2017-02-23, terminated 2019-07-09. It names one FDA 510(k) clearance: K813338. Product: JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;. Reason: The integrity of the sterile packaging is potentially compromised..

Recalling firm: Carefusion 2200 Inc
Classification: Class II
Status: Terminated
Initiated: 2017-02-23
Terminated: 2019-07-09
Firm location: Vernon Hills, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K813338 — BIOPSY NEEDLES & TRAYSAmerican Pharmaseal Div. Ahsc·cleared 1982-01-28

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

JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;

Reason for recall

The integrity of the sterile packaging is potentially compromised.

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