FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0076-06
- Recalling firm
- Ethicon, Inc
- 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.
- Status
- Terminated
- Initiated
- 2005-08-31
- Posted
- 2005-10-21
- Terminated
- 2006-07-03
- 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.
- Lot, serial or model codes
- Product code 2179 Lot 520198, exp June 2010; Lot 520200, exp June 2010.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCY
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28