—#94456

Product

Control Syringe, 10ml, CAT No: CCX010E Version B, Sterile R, Merit Medical Systems, Inc. Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are intended to be used as sterile, disposable, single use syringes.

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K875196
Affected lot / code info: Lot Number H137552

Why it was recalled

Small holes in the packaging may render the product non-sterile.

Root cause (FDA determination)

Employee error

Action the firm took

Merit Medical sent an Urgent Product Recall Notice dated September 9, 2010, to all sales representatives. The notice identified the product, the problem, and the action to be taken by the sales representatives and their customers. Sales representatives were instructed to contact all customers via telephone and instruct them to immediately discontinue use and quarantine any unused product. Recall Notification Forms were to be completed and signed by the site representative and the customer and faxed to Merit customer service at 801-208-3378. If customers were returning affected products they were to place the completed original Recall Notification Form in the box with the products to be returned, write the RGA# on the shipping box and return by Federal Express 2nd Day air to: RGA Department Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095-2416 For any questions regarding this recall call 801-316-4822 or 801-208-4365.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA, including IL, PA, WI and WV and the countries China, Greece, Hong Kong, Japan, New Zealand and Spain.

Timeline

Recall initiated: 2010-09-09
Posted by FDA: 2010-10-15
Terminated: 2011-03-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94456. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.