Z-1661-2008

Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures

Name: Z-1661-2008 Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures
Creator: Ascent Healthcare Solutions, Inc.
Published: 2008-03-11
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2008-03-11 / Terminated / root cause: manufacturing process

FDA source

Ascent Healthcare Solutions, Inc. began a recall of Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures on 2008-03-11. The reason FDA records is "Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products". 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-1661-2008
Status: Terminated
Initiated: 2008-03-11
Posted: 2008-09-19
Terminated: 2012-06-29
Recalling firm: Stryker Sustainability Solutions
Product: Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures.
Product code: JOW Sleeve, Limb, Compressible
Reason for recall: Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at [email protected].
Quantity in commerce: 360 of 365
Distribution: Class II Recall - Nationwide Distribution.
Product codes and lots: Catalog No. 5329, Lot No 135736

Product code JOW

K012403Class IIVanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. / cleared 2001-10-17

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)