Recall Z-2366-2008 ยท FMF Syringe, Piston
Merit Medical Systems, Inc.
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.
| Date | Sep 21, 2008 (initiated Jul 9, 2008) |
| Status | Terminated |
| Reason | Control Syringes may be non-sterile due to holes in the packaging. |
| Root cause | 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 | 519 units |
| Distribution | CA, FL, GA, ID, IL, IN, KS, LA, MO, MT, OH, PA, TN, and WA. Foreign distribution to Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K875196 | DISPOSABLE CORONARY CONTROL SYRINGE 12CC Merit Medical Systems, Inc., Feb 11, 1988 |