FDA Recall
Terminated
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: Z-1424-2018
·
Initiated February 23, 2017
Recall
- Recall Number
- Z-1424-2018
- Event Number
- 76620
- Firm
- Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845
- FEI Number
- 3008002452
- Product Code
- FSH
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- February 23, 2017
- Terminated
- July 9, 2019
Description
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;
Reason
The integrity of the sterile packaging is potentially compromised.
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.
Distribution
Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam