Recall Z-0818-2019 ยท DWO Needle, Biopsy, Cardiovascular
Angiotech (Manan Medical Products, Inc.)
Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
| Date | Dec 18, 2018 |
| Status | Terminated |
| Reason | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line |
| Root cause | Equipment maintenance |
| Action | Argon Medical Devices notified customers on about 12/18/2018 via "Urgent - Field Safety Notice" letter. Instructions included complete and return the response form a quickly as possible, return all affected product to their Argon Wheeling facility, and to provide the recall notification to all who need to be aware within the organization as well as any organization where the affected product was distributed. |
| Quantity | 1,404 units |
| Distribution | Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K890925 | MANAN BONE MARROW BIOPSY NEEDLE Manan Medical Products, Inc., Apr 11, 1989 |