Recall Z-0076-06 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Ethicon, Inc
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.
| Date | Oct 21, 2005 (initiated Aug 31, 2005) |
| Status | Terminated |
| Reason | Two lots of J-VAC Drain Reservors were shipped to Japan prior to sterilization and were released. |
| Root 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 | 4630 units |
| Distribution | The two lots were distributed to Japan. No units were distributed in the US. No government accounts are affected. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.