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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 July 09, 2008
Date Posted September 21, 2008
Recall Status1 Terminated 3 on November 03, 2008
Recall Number Z-2367-2008
Recall Event ID 49002
510(K)Number K875196  
Product Classification Syringe - Product Code FMF
Product 12ml Control Syringe, REF/CAT No.: CCS601 Version B, Sterile R, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty.
Code Information Lot Number: F620653
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan UT 84095
For Additional Information Contact Toni Cox
801-208-4408
Manufacturer Reason
for Recall		 Control Syringes may be non-sterile due to holes in the packaging.
FDA Determined
Cause 2		 Process control
Action Urgent Product Recall letters dated 07/09/08, were faxed on 07/09/2008 to consignees/sales reps. The letter instructed consignees/sales reps to contact their customers by phone or visit to provide recall information and instructions. Customers were told to immediately discontinue use and to quarantine all affected products. A Product Retrieval Form was provided that was to be signed by the site representative. Contact Merit Medical at 1-801-208-4408 for assistance.
Quantity in Commerce 679 units
Distribution CA, FL, GA, ID, IL, IN, KS, LA, MO, MT, OH, PA, TN, and WA. Foreign distribution to Japan.
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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