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U.S. Department of Health and Human Services

Class 2 Device Recall JVAC

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  Class 2 Device Recall JVAC see related information
Date Initiated by Firm August 31, 2005
Date Posted October 21, 2005
Recall Status1 Terminated 3 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.
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 2		 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.
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