Control Syringe, 12ml, CAT No: CCS600 Version B, Sterile R, Merit Medical Systems, Inc. Used for hand injections of cont
FDA device recall Z-0061-2011 · posted 2010-10-15 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Small holes in the packaging may render the product non-sterile.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 10,000 units
- Distribution
- Worldwide Distribution - USA, including IL, PA, WI and WV and the countries China, Greece, Hong Kong, Japan, New Zealand and Spain.
- Date initiated
- 2010-09-09
- Date posted
- 2010-10-15
- Date terminated
- 2011-03-21
- Location
- South Jordan, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE CORONARY CONTROL SYRINGE 12CC (K875196) | Merit Medical Systems, Inc. | 1988-02-11 |