Z-0063-2011

Control Syringe, 10ml, CAT No: CCX010 Version B, Sterile R, Merit Medical Systems, Inc. Used for hand...

Name: Z-0063-2011 Control Syringe, 10ml, CAT No: CCX010 Version B, Sterile R, Merit Medical Systems, Inc. Used for hand...
Creator: Merit Medical Systems, Inc.
Published: 2010-09-09
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2010-09-09 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Control Syringe, 10ml, CAT No: CCX010 Version B, Sterile R, Merit Medical Systems, Inc. Used for hand injections of contrast medium during Coronary or... on 2010-09-09. The reason FDA records is "Small holes in the packaging may render the product non-sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0063-2011
Status: Terminated
Initiated: 2010-09-09
Posted: 2010-10-15
Terminated: 2011-03-21
Recalling firm: Merit Medical Systems, Inc.
Product: Control Syringe, 10ml, CAT No: CCX010 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.
Product code: FMF Syringe, Piston
Reason for recall: Small holes in the packaging may render the product non-sterile.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 2993 units
Distribution: Worldwide Distribution - USA, including IL, PA, WI and WV and the countries China, Greece, Hong Kong, Japan, New Zealand and Spain.
Product codes and lots: Lot Number H137546

Product code FMF

K875196Class IIDisposable Coronary Control Syringe 12CcMerit Medical Systems, Inc. / cleared 1988-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)