Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242
This recall has been terminated (originally issued January 29, 2008).
- Company
- Ethicon Endo-Surgery Inc
- Recall Initiated
- November 6, 2007
- Posted
- January 29, 2008
- Terminated
- December 9, 2009
- Recall Number
- Z-0565-2008
- Quantity
- 2,844
- Firm Location
- Cincinnati, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.
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 Venezuela.
Lot / Code Info
Lot No: D4HZ9Y.
Root 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.