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U.S. Department of Health and Human Services

Class 2 Device Recall EZIO

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  Class 2 Device Recall EZIO see related information
Date Initiated by Firm March 31, 2014
Date Posted September 22, 2014
Recall Status1 Terminated 3 on January 30, 2015
Recall Number Z-2672-2014
Recall Event ID 67912
510(K)Number K052408  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455
Code Information Part number 9079-VC-005; lot code 3606455
Recalling Firm/
Manufacturer		 Vidacare Corporation
4350 Lockhill Selma Rd
Suite 150
San Antonio TX 78249-2162
For Additional Information Contact
210-375-8500
Manufacturer Reason
for Recall		 The voluntary recall is due to the needle set not meeting its specifications.
FDA Determined
Cause 2		 Material/Component Contamination
Action Vidacare sent an Urgent Medical Device Recall Notification to all of its customers on March 31, 2014.The letter identified the product the problem and the action to be taken by the customers. The firm asked its customers to return the affected lot for a replacement. Customers were instructed: 1. If you have affected stock, immediately discontinue use and quarantine any product with the part number and lot number as identified above 2 To return product. complete the enclosed Medical Device Recall Acknowledgment and Return Response Form and fax it to 1 866-431-6194, Attn "Customer Service" This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Vidacare Corporation and to facilitate replacement product if one has not already been provided 3. If you have already used the affected stock. please complete the enclosed Medical Device Recall Acknowledgement and Return Response Form and fax it to 1-866-431- 6194, Attn" Customer Service". This will allow us to document your receipt of the letter. Vidacare Corporation is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-479-8500.
Quantity in Commerce 172
Distribution Worldwide Distribution-US (nationwide) including the states of LA, NY, CA, CT, WA, AK, NJ, TX, GA, MI, MO, MD, FL, KY, VA, OH, UT, SC, NC, IN, AZ, MN, IL, TN, OK, KS, NE, MT, MS, AR, ID, WV and PA., and Internationally to Canada
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 = FMI and Original Applicant = VIDACARE CORPORATION
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