Z-1504-2008

Surgivac Wound Drainage Device, 400 ml Surgivac Component Kit, sterile, latex free, Rx only; Zimmer, Swindon...

Name: Z-1504-2008 Surgivac Wound Drainage Device, 400 ml Surgivac Component Kit, sterile, latex free, Rx only; Zimmer, Swindon...
Creator: Zimmer Inc.
Published: 2008-01-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-01-29 / Terminated / root cause: packaging

FDA source

Zimmer Inc. began a recall of Surgivac Wound Drainage Device, 400 ml Surgivac Component Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio... on 2008-01-29. The reason FDA records is "The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1504-2008
Status: Terminated
Initiated: 2008-01-29
Posted: 2008-09-19
Terminated: 2009-11-12
Recalling firm: Zimmer GmbH
Product: Surgivac Wound Drainage Device, 400 ml Surgivac Component Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-5300-004-10.
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Reason for recall: The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Consignees were notified via recall letter dated 1/29/08 to locate and return the affected product. The recall action was expanded to additional products/lots via recall letter dated 3/17/08. Custom kit packers were instructed to notify their customers.
Distribution: Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
Product codes and lots: All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.

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)