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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = OEI
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