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.
FDA Recall Z-2367-2008 · Posted 2008-09-21
Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeFMF
Date Initiated2008-07-09
Date Terminated2008-11-03
Product Quantity679 units
Reason for Recall
Control Syringes may be non-sterile due to holes in the packaging.
Firm 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.
Root Cause
Process control
Distribution Pattern
CA, FL, GA, ID, IL, IN, KS, LA, MO, MT, OH, PA, TN, and WA. Foreign distribution to Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.