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U.S. Department of Health and Human Services

Class 2 Device Recall Elutia Hubless Coated Silicone Wound Drain

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 Class 2 Recall
Elutia Hubless Coated Silicone Wound Drain
see related information
Date Posted March 11, 2013
Recall Status1 Terminated on July 08, 2013
Recall Number Z-0936-2013
Recall Event ID 64326
Premarket Notification
510(K) Number
K063245 
Product Classification Drainage Catheter With Antibiotic - Product Code OEI
Product 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.
Code Information 005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211
Recalling Firm/
Manufacturer
Bacterin International, Inc.
600 Cruiser Ln
Belgrade, Montana 59714-9719
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Janet Seidel
406-388-0480
Manufacturer Reason
for Recall
A portion of a silicone wound drain was found to be cracked.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Consignees were informed of the recall via e-mail beginning 1/28/13 with a request for a return response. This was followed by a "Voluntary Product Recall Information" letter dated 2/13/13 that described the product issue and provided recommended actions. The firm asked for all product to be returned to them.
Quantity in Commerce 15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee
Distribution 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OEI and Original Applicant = BACTERIN INTERNATIONAL INC.
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