J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable system used
FDA device recall Z-0076-06 · posted 2005-10-21 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc
- Reason for recall
- Two lots of J-VAC Drain Reservors were shipped to Japan prior to sterilization and were released.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GCY
- Quantity affected
- 4630 units
- Distribution
- The two lots were distributed to Japan. No units were distributed in the US. No government accounts are affected.
- Date initiated
- 2005-08-31
- Date posted
- 2005-10-21
- Date terminated
- 2006-07-03
- Location
- Somerville, NJ
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