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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description Cascade Autologous Platelet System Rx Distributed by ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Manufactured by: MTF Musculoskeletal Transplant Foundation 125 May Street Edison, NJ www.mtf.org
Recall Number B-0103-14
Classification Class I
Code Info Product Code 910046 Lot number 107692
Product Distributed Qty 1 unit
Reason For Recall A single lot of CASCADE Autologous Platelet System, containing a component (yellow tube) that may have higher than normal endotoxin levels, was distributed.

Event Detail

Event Id 66045
Product Type Biologics
Status Ongoing
Recalling Firm Musculoskeletal Transplant Foundation
City Edison
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide; Spain Portugal