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Terminated

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.

FDA Recall Z-0076-06 · Posted 2005-10-21

Recalling FirmEthicon, Inc
Recall StatusTerminated
Product CodeGCY
Date Initiated2005-08-31
Date Terminated2006-07-03
Product Quantity4630 units

Reason for Recall

Two lots of J-VAC Drain Reservors were shipped to Japan prior to sterilization and were released.

Firm 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.

Root Cause

Other

Distribution Pattern

The two lots were distributed to Japan. No units were distributed in the US. No government accounts are affected.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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