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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Event Detail

Event ID 68093
Product Type Devices
Status Ongoing
Recalling Firm Biorep Technologies
City Miami
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-19
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Distribution only to MN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery. Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03) Class II The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component. 80 boxes (480 units) Z-1538-2014