Recall Z-0565-2008
Ethicon Endo-Surgery Inc · initiated November 6, 2007
Product
Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242
Codes / lots: Lot No: D4HZ9Y.
Reason for recall
Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-0565-2008
- Initiated
- November 6, 2007
- Posted by FDA
- January 29, 2008
- Terminated
- December 9, 2009
- Product code
- GDI – Dissector, Surgical, General & Plastic Surgery
- 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 Rico, Republic of Panama, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, and…
- Recalling firm
- Ethicon Endo-Surgery Inc, Cincinnati, OH