FDA Medical Device Recalls (openFDA)
Carefusion 2200 Inc: 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.
- Recall number
- Z-2111-2010
- Recalling firm
- Carefusion 2200 Inc
- 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.
- Status
- Terminated
- Initiated
- 2010-06-25
- Posted
- 2010-07-28
- Terminated
- 2011-01-24
- Reason
- The introducer needle is only 10 cm in length instead of the required 15 cm.
- Root cause
- 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
- 65 units
- Distribution
- Nationwide distribution: California, Florida, Georgia, Illinois, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania.
- Lot, serial or model codes
- Catalog number CCH2220, Lot D09121745
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDF
- Firm FEI
- 3008002452
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28