Z-1454-2008

Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-703-10; 400 ml INF...

Name: Z-1454-2008 Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-703-10; 400 ml INF...
Creator: Zimmer Inc.
Published: 2008-01-31
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-01-31 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-703-10; 400 ml INF. CNTRL. Kit W/ 3/16" Drain Spec., 4.8mm, 15Fr., PVC... on 2008-01-31. The reason FDA records is "Leakage: The kits may disassemble at the fluid collection port, which would present a risk of exposure to blood borne pathogens to health care providers should it occur during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1454-2008
Status: Terminated
Initiated: 2008-01-31
Posted: 2008-04-09
Terminated: 2009-11-12
Recalling firm: Zimmer GmbH
Product: Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-703-10; 400 ml INF. CNTRL. Kit W/ 3/16" Drain Spec., 4.8mm, 15Fr., PVC, 107cm, soft, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Reason for recall: Leakage: The kits may disassemble at the fluid collection port, which would present a risk of exposure to blood borne pathogens to health care providers should it occur during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified via Urgent Infection Control Recall letter dated 1/31/08 to examine their inventory and return the recalled lots. Custom kit packers were instructed in the same letter to recall these products/lots from their own customers.
Quantity in commerce: 34,354 (Recalls Z-1448/1458-2008)
Distribution: Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
Product codes and lots: Lot Numbers: 60045265, 60101564, 60154830, 60196965, 60333503, 60412506, 60453016 and 60633939.

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)