Recall Z-0062-2011 ยท FMF Syringe, Piston
Merit Medical Systems, Inc.
Control Syringe, 12ml, CAT No: CCS100 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.
| Date | Oct 15, 2010 (initiated Sep 9, 2010) |
| Status | Terminated |
| Reason | Small holes in the packaging may render the product non-sterile. |
| Root cause | Employee error |
| Action | 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 |
| Quantity | 2337 units |
| Distribution | Worldwide Distribution - USA, including IL, PA, WI and WV and the countries China, Greece, Hong Kong, Japan, New Zealand and Spain. |
| 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 |