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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Event Detail

Event ID 64326
Product Type Devices
Status Ongoing
Recalling Firm Bacterin International, Inc.
City Belgrade
State MT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern 13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage. 005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211 Class II A portion of a silicone wound drain was found to be cracked. 15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee Z-0936-2013