—#66325

Product

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

FDA product code: GDI — Dissector, Surgical, General & Plastic Surgery
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K984240
Affected lot / code info: Lot No: D4HZ9Y.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Cincinnati, Ohio 45242-2803

Distribution

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.

Timeline

Recall initiated: 2007-11-06
Posted by FDA: 2008-01-29
Terminated: 2009-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66325. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.