Carefusion 2200 Inc: JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;

Recall number

Z-1424-2018

Recalling firm

Carefusion 2200 Inc

Product

JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; 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

not on file

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.) TJC3513 / LOT 0000848831, 0000851431, 0000854856; Product Code: b.) TJC4008 / LOT 0000841227, 0000846706, 0000848560, 0000849684, 0000853455; c.) TJC4011 / LOT 0000840667, 0000841228, 0000845874, 0000849717, 0000850937, 0000852121; d.) TJC6008 / LOT 0000841216, 0000848569, 0000851432, 0000852122, 0000853458; e.) TJC6011 / LOT 0000841124, 0000848571, 0000853975

510(k) numbers

["K913306"]

PMA numbers

not on file

Product code

FSH

Firm FEI

3008002452

Firm city

Vernon Hills

Firm state

IL

Firm country

not on file

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

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