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.
Recall
- Recall Number
- Z-2366-2008
- Event Number
- 49002
- Firm
- Merit Medical Systems, Inc.
- FEI Number
- 1721504
- Product Code
- FMF
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 9, 2008
- Posted
- September 21, 2008
- Terminated
- November 3, 2008
- Address
- 1600 Merit Pkwy South, Jordan, UT, 84095
Description
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.
Control Syringes may be non-sterile due to holes in the packaging.
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.
CA, FL, GA, ID, IL, IN, KS, LA, MO, MT, OH, PA, TN, and WA. Foreign distribution to Japan.
519 units