FDA Medical Device Recalls (openFDA)
Carefusion 2200 Inc: ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;
- Recall number
- Z-1423-2018
- Recalling firm
- Carefusion 2200 Inc
- Product
- ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;
- Status
- Terminated
- Initiated
- 2017-02-23
- Posted
- not on file
- Terminated
- 2019-07-09
- Reason
- The integrity of the sterile packaging is potentially compromised.
- Root cause
- Package design/selection
- Action
- 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.
- Quantity
- a.) 13,010 units b.) 2116 units
- Distribution
- Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
- Lot, serial or model codes
- Product Code: a.) TIN3015/ LOT 0000836578, 0000841213, 0000841215, 0000842719, 0000842721, 0000845423, 0000848061, 0000849715, 0000850938, 0000852076, 0000854859; Product Code: b.) TIN3018/ LOT 0000836574, 0000841212, 0000852078
- 510(k) numbers
- ["K913306","K930217"]
- PMA numbers
- not on file
- Product code
- FSH
- Firm FEI
- 3008002452
- Firm city
- Vernon Hills
- 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