Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x

FDA device recall Z-2111-2010 · posted 2010-07-28 · Terminated

Recall details

Recalling firm

Carefusion 2200 Inc

Reason for recall

The introducer needle is only 10 cm in length instead of the required 15 cm.

Action taken

Cardinal Health, on behalf of CareFusion, telephoned the customers on June 15, 2010 and sent a follow-up "URGENT: PRODUCT RECALL" letter on the same date via UPS next day air. The letter describes product, problem, and action taken by customers. The customers were instructed to immediately stop using affected product, return the enclosed acknowledgment form via fax to 847-686-9101 (note: Cardinal Health is required to confirm receipt of this notification from the customers), notify any customers to whom they may have distributed product to, contact CareFusion Customer Service at 800-653-6827 to arrange for credit and return of the affected product, and send the affected product to CareFusion, 1240 Waukegan Rd, Waukegan, IL 60085, Attn: Scott Fitzer, after obtaining an RMA/RGA number from CareFusion. If you have any questions, please contact 800-292-9332.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

GDF

Quantity affected

65 units

Distribution

Nationwide distribution: California, Florida, Georgia, Illinois, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania.

Date initiated

2010-06-25

Date posted

2010-07-28

Date terminated

2011-01-24

Location

Waukegan, IL