Recall Z-1422-2018 ยท FSH Tray, Surgical, Needle
Carefusion 2200 Inc
JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
| Date | Feb 23, 2017 |
| Status | Terminated |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K813338 | BIOPSY NEEDLES & TRAYS American Pharmaseal Div. Ahsc, Jan 28, 1982 |