Class 2 Device Recall Coronary Control Syringe

• Date Initiated by Firm: September 09, 2010
• Date Posted: October 15, 2010
• Recall Status: Terminated on March 21, 2011
• Recall Number: Z-0061-2011
• Recall Event ID: 56756
• 510(K)Number: K875196
• Product Classification: Syringe, piston - Product Code FMF
• Product: Control Syringe, 12ml, CAT No: CCS600 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 H135352
• 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: 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: 10,000 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