| Class 2 Device Recall Coronary Control Syringe | |
Date Initiated by Firm | July 09, 2008 |
Date Posted | September 21, 2008 |
Recall Status1 |
Terminated 3 on November 03, 2008 |
Recall Number | Z-2366-2008 |
Recall Event ID |
49002 |
510(K)Number | K875196 |
Product Classification |
Syringe - Product Code FMF
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Product | 10ml Control Syringe, REF/CAT No.: CCX011 Version A, Sterile EO, 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: F621152 |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc. 1600 Merit Pkwy South Jordan UT 84095
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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 | 519 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 |
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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 = FMF
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