Recall Z-0253-04 ยท GWD Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
Power Medical Interventions
SurgAssist System Circular Stapler DLU 33mm
| Date | Dec 19, 2003 (initiated Nov 20, 2003) |
| Status | Terminated |
| Reason | improper staple formation or anvil jam |
| Root cause | Other |
| Action | On 11/20/03, the recalling firm sent recall notices via overnight carrier to all customers who have been shippped and/or sold the product. The recall notice requested the return of the devices. |
| Quantity | 350 units |
| Distribution | The products were shipped to medical facilities and sales representatives nationwide. The product was also shipped to distributors in the United Kingdom, France, Scotland, Belgium, Germany, Israel, Italy, Japan, Spain, Portugal, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032701 | SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33) Power Medical Interventions, Inc., Sep 30, 2003 |