Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery…

Date posted by the FDA

Jan. 29, 2008

Status

Terminated

Filed by

Ethicon Endo-Surgery Inc

Product

Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242

Reason

Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.

Distribution pattern

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.

Quantity

2,844

Codes and lots

Lot No: D4HZ9Y.

Recall started

Nov. 6, 2007

Device type

Dissector, Surgical, General & Plastic Surgery

Root cause (FDA)

Process control

What the company told customers

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.

Recall number

Z-0565-2008

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0565-2008. The agency record governs; check it and the company before acting.