—#72502

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.

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K875196
Affected lot / code info: Lot Number: F621152

Why it was recalled

Control Syringes may be non-sterile due to holes in the packaging.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 Merit Pkwy South, Jordan, Utah 84095

Distribution

Distribution pattern: CA, FL, GA, ID, IL, IN, KS, LA, MO, MT, OH, PA, TN, and WA. Foreign distribution to Japan.

Timeline

Recall initiated: 2008-07-09
Posted by FDA: 2008-09-21
Terminated: 2008-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72502. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.