Class 2 Device Recall JVAC

• Date Initiated by Firm: August 31, 2005
• Date Posted: October 21, 2005
• Recall Status: Terminated on July 03, 2006
• Recall Number: Z-0076-06
• Recall Event ID: 33336
• Product Classification: Apparatus, Suction, Single Patient Use, Portable, Nonpowered - Product Code GCY
• Product: J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable system used for closed wound drainage. This system is composed of two parts: the J-VAC Reservoir and Suction Drains.
• Code Information: Product code 2179 Lot 520198, exp June 2010; Lot 520200, exp June 2010.
• FEI Number: 2210968
• Recalling Firm/ Manufacturer: Ethicon, Inc; US Highway 22 West; Somerville NJ 08876
• For Additional Information Contact: Cindy Crosby; 908-218-3365
• Manufacturer Reason for Recall: Two lots of J-VAC Drain Reservors were shipped to Japan prior to sterilization and were released.
• FDA Determined Cause: Other
• Action: Ethicon notified Japan of the recall on 9/2/2005 via phone call and e-mail. This product is direct shipped from Johnson & Johnson Hospital Services distribution center to Japan JJKK.
• Quantity in Commerce: 4630 units
• Distribution: The two lots were distributed to Japan. No units were distributed in the US. No government accounts are affected.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.