Date Initiated by Firm |
January 28, 2013 |
Date Posted |
March 11, 2013 |
Recall Status1 |
Terminated 3 on July 08, 2013 |
Recall Number |
Z-0936-2013 |
Recall Event ID |
64326 |
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 MT 59714-9719
|
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 |
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = OEI and Original Applicant = BACTERIN INTERNATIONAL INC.
|