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Terminated

Color Cuff II, Double Port Single Bladder - Reprocessed Sterile device -- Pneumatic tourniquet.

FDA Recall Z-1678-2008 · Posted 2008-09-19

Recalling FirmAscent Healthcare Solutions, Inc.
Recall StatusTerminated
Product CodeKCY
Date Initiated2008-03-11
Date Terminated2012-06-29
Product Quantity20 of 20

Reason for Recall

Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

Firm 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].

Root Cause

Process control

Distribution Pattern

Class II Recall - Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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