Z-0076-06

J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable...

Name: Z-0076-06 J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable...
Creator: Ethicon, Inc
Published: 2005-08-31
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2005-08-31 / Terminated / root cause: sterility

FDA source

Ethicon, Inc began a recall of 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... on 2005-08-31. The reason FDA records is "Two lots of J-VAC Drain Reservors were shipped to Japan prior to sterilization and were released". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0076-06
Status: Terminated
Initiated: 2005-08-31
Posted: 2005-10-21
Terminated: 2006-07-03
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.
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Reason for recall: Two lots of J-VAC Drain Reservors were shipped to Japan prior to sterilization and were released.
Root cause tag: sterility
FDA 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 in commerce: 4630 units
Distribution: The two lots were distributed to Japan. No units were distributed in the US. No government accounts are affected.
Product codes and lots: Product code 2179 Lot 520198, exp June 2010; Lot 520200, exp June 2010.

Product code GCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)