Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti
FDA device recall Z-0565-2008 · posted 2008-01-29 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery Inc
- Reason for recall
- Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GDI
- Quantity affected
- 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, Colombi
- Date initiated
- 2007-11-06
- Date posted
- 2008-01-29
- Date terminated
- 2009-12-09
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOPATH ENDOSCOPIC INSTRUMENTS (K984240) | Ethicon Endo-Surgery, Inc. | 1999-06-22 |