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U.S. Department of Health and Human Services

Class 2 Device Recall Temno

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  Class 2 Device Recall Temno see related information
Date Initiated by Firm June 25, 2010
Date Posted July 28, 2010
Recall Status1 Terminated 3 on January 24, 2011
Recall Number Z-2111-2010
Recall Event ID 56085
Product Classification Guide, needle, surgical - Product Code GDF
Product Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm); sterile, for single use only sets, 5 sets per case; CareFusion, McGaw Park, IL 60085 USA, Made in Dominican Republic; REF CCH2220

For use in soft tissue aspiration such as breast, kidney, liver, lung, thyroid, lymph nodes and other various soft tissue masses. It is not intended for use in the bone.
Code Information Catalog number CCH2220, Lot D09121745
Recalling Firm/
Manufacturer		 Carefusion 2200 Inc
1500 S Waukegan Rd
Mpwm Bldg.
Waukegan IL 60085-6728
For Additional Information Contact
847-578-6610
Manufacturer Reason
for Recall		 The introducer needle is only 10 cm in length instead of the required 15 cm.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action 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.
Quantity in Commerce 65 units
Distribution Nationwide distribution: California, Florida, Georgia, Illinois, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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