Recall Z-0565-2008 ยท GDI Dissector, Surgical, General & Plastic Surgery
Ethicon Endo-Surgery Inc
Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242
| Date | Jan 29, 2008 (initiated Nov 6, 2007) |
| Status | Terminated |
| Reason | Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices. |
| Root cause | Process control |
| Action | Endopath sent consignees an Urgent Device Recall notification letter on or about 11/15/07, informing them that the possibility exists that damage to the packaging of this product may have compromised the sterility of the product. The firms were told to examine their inventory, and remove all affected product. All consignees were instructed to complete the Business Reply Form; even if they did not have any product. Recalled products are to be returned to Ethicon for a credit. |
| Quantity | 2,844 |
| Distribution | Worldwide, USA including states of AL, AR, AZ, CA, CO, DE, FL, GA, IL, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NV, NY, OH, PA, RI, TN, TX, AND WA, and countries of Austria, Belgium, Canada, China, Colombia, Czech Republic, Ecuador, Egypt, Greece, Hong Kong, Italy, Japan, Korea, Mexico, Portugal, Puerto |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984240 | ENDOPATH ENDOSCOPIC INSTRUMENTS Ethicon Endo-Surgery, Inc., Jun 22, 1999 |