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Terminated

Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''.

FDA Recall Z-1154-06 · Posted 2006-06-17

Recalling FirmAbbott Spine
Recall StatusTerminated
Product CodeKKX
Date Initiated2006-05-15
Date Terminated2007-09-25
Product Quantity326 units.

Reason for Recall

Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results.

Firm Action

Firm notified sales agents of recall via telephone on 05/15/06 and requested product returns for destruction

Root Cause

Other

Distribution Pattern

NATIONWIDE-Drapes consigned to sales agents located in CA, FL, IL, MD, MI, OK, OH, TX, and WI.

Official Source

View FDA Recall →

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

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