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U.S. Department of Health and Human Services

Class 2 Device Recall Elutia Surgical Wound Drain

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  Class 2 Device Recall Elutia Surgical Wound Drain see related information
Date Initiated by Firm May 15, 2014
Date Posted June 02, 2014
Recall Status1 Terminated 3 on June 02, 2014
Recall Number Z-1680-2014
Recall Event ID 68305
510(K)Number K063245  
Product Classification Drainage catheter with antibiotic - Product Code OEI
Product Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***"
Two different sizes, 10 units per box:
19 Fr Round Hubless part number 7110;
24 Fr Round Hubless part number 7118.

AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.
Code Information 19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..
Recalling Firm/
Manufacturer		 Bacterin International, Inc.
600 Cruiser Ln
Belgrade MT 59714-9719
For Additional Information Contact Casey Ming
406-388-0480 Ext. 128
Manufacturer Reason
for Recall		 The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized
FDA Determined
Cause 2		 Use error
Action Bacterin sent e-mail and FedEx letter with return receipt request to it's single consignee on May 15, 2014. Consignee is asked to separate the recalled product in a secure location for return to Bacterin International, Inc. Consignee is asked to complete tracking/verification form included in the letter/e-mail and call 1-888-886-9354 from 8:00AM to 5:00PM (Mountain Time) or send an e-mail to CS@Bacterin.com to obtain a Return Authorization (RA) number.
Quantity in Commerce 390
Distribution Distributed to one foreign consignee in Lebanon.
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.
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