Recall Z-1422-2018
Carefusion 2200 Inc · initiated February 23, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
Codes / lots: Product Code: SN1015X / LOT 0000840334 ; Product Code: SN1016X / LOT 0000848028 ; Product Code: SN1017X / LOT 0000848018 ; Product Code SN7016X / LOT 0000848017
Reason for recall
The integrity of the sterile packaging is potentially compromised.
FDA-determined cause: Package design/selection
Action taken
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.
Details
- Recall number
- Z-1422-2018
- Initiated
- February 23, 2017
- Terminated
- July 9, 2019
- Product code
- FSH – Tray, Surgical, Needle
- Quantity
- 790 units
- Distribution
- Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
- Recalling firm
- Carefusion 2200 Inc, Vernon Hills, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1421-2018 Class II | Manometer, 550 ml three-Way Stopcock; STERILE;The integrity of the sterile packaging is potentially compromised. | 02/23/2017Terminated |
| Z-1423-2018 Class II | ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;The integrity of the sterile packaging is potentially compromised. | 02/23/2017Terminated |
| Z-1424-2018 Class II | JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6…The integrity of the sterile packaging is potentially compromised. | 02/23/2017Terminated |
| Z-1425-2018 Class II | JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6…The integrity of the sterile packaging is potentially compromised. | 02/23/2017Terminated |
| Z-1426-2018 Class II | Thoracentesis/ Paracentesis Kit 10/CS; STERILE;The integrity of the sterile packaging is potentially compromised. | 02/23/2017Terminated |