Atlas FDA

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

FDA device recall Z-1154-06 · posted 2006-06-17 · Terminated

Recall details

Recalling firm
Abbott Spine
Reason for recall
Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results.
Action taken
Firm notified sales agents of recall via telephone on 05/15/06 and requested product returns for destruction
Root cause
Other
Status
Terminated
Product code
KKX
Quantity affected
326 units.
Distribution
NATIONWIDE-Drapes consigned to sales agents located in CA, FL, IL, MD, MI, OK, OH, TX, and WI.
Date initiated
2006-05-15
Date posted
2006-06-17
Date terminated
2007-09-25
Location
Austin, TX

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