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U.S. Department of Health and Human Services

Class 2 Device Recall Coronary Control Syringe

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  Class 2 Device Recall Coronary Control Syringe see related information
Date Initiated by Firm September 09, 2010
Date Posted October 15, 2010
Recall Status1 Terminated 3 on March 21, 2011
Recall Number Z-0063-2011
Recall Event ID 56756
510(K)Number K875196  
Product Classification Syringe, piston - Product Code FMF
Product Control Syringe, 10ml, CAT No: CCX010 Version B, Sterile R, Merit Medical Systems, Inc.
Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are intended to be used as sterile, disposable, single use syringes.
Code Information Lot Number H137546
Recalling Firm/
Manufacturer
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact
801-316-4932
Manufacturer Reason
for Recall
Small holes in the packaging may render the product non-sterile.
FDA Determined
Cause 2
Employee error
Action Merit Medical sent an Urgent Product Recall Notice dated September 9, 2010, to all sales representatives. The notice identified the product, the problem, and the action to be taken by the sales representatives and their customers. Sales representatives were instructed to contact all customers via telephone and instruct them to immediately discontinue use and quarantine any unused product. Recall Notification Forms were to be completed and signed by the site representative and the customer and faxed to Merit customer service at 801-208-3378. If customers were returning affected products they were to place the completed original Recall Notification Form in the box with the products to be returned, write the RGA# on the shipping box and return by Federal Express 2nd Day air to: RGA Department Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095-2416 For any questions regarding this recall call 801-316-4822 or 801-208-4365.
Quantity in Commerce 2993 units
Distribution Worldwide Distribution - USA, including IL, PA, WI and WV and the countries China, Greece, Hong Kong, Japan, New Zealand and Spain.
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 = FMF and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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