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 | |
| 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 |
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