Recalls / —

—#154882

Product

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

FDA product code

FSH — Tray, Surgical, Needle

Device class

Class 1

Medical specialty

General, Plastic Surgery

510(k) numbers

K813338

Affected lot / code info

Product Code: SN1015X / LOT 0000840334 ; Product Code: SN1016X / LOT 0000848028 ; Product Code: SN1017X / LOT 0000848018 ; Product Code SN7016X / LOT 0000848017

Why it was recalled

The integrity of the sterile packaging is potentially compromised.

Root cause (FDA determination)

Package design/selection

Action the firm took

On 2/23/2017, firm notified customers of recall via mailed letter. The letter included a recall response form. Customers were directed to either return the affected product along with the response form or destroy it and return the response form, indicating the product had been destroyed. All affected product will be destroyed.

Recalling firm

Firm

Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

Distribution

Distribution pattern

Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

Timeline

Recall initiated

2017-02-23

Terminated

2019-07-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #154882. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.