Recall Z-1424-2018— Carefusion 2200 Inc

Name: FDA recall Z-1424-2018
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: K913306. Product: JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; 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

K913306 — BONE-TEMNO/STERNUM-TEMNOProact, Ltd.·cleared 1991-11-01

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 (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; 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.