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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

Product Description 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.
Recall Number Z-0936-2013
Classification Class II
Code Info 005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211
Product Distributed Qty 15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee
Reason For Recall A portion of a silicone wound drain was found to be cracked.

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 E-Mail
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