Z-2367-2008

12ml Control Syringe, REF/CAT No.: CCS601 Version B, Sterile R, Merit Medical Systems, Inc., South Jordan...

Name: Z-2367-2008 12ml Control Syringe, REF/CAT No.: CCS601 Version B, Sterile R, Merit Medical Systems, Inc., South Jordan...
Creator: Merit Medical Systems, Inc.
Published: 2008-07-09
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2008-07-09 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of 12ml Control Syringe, REF/CAT No.: CCS601 Version B, Sterile R, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of... on 2008-07-09. The reason FDA records is "Control Syringes may be non-sterile due to holes in the packaging". 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-2367-2008
Status: Terminated
Initiated: 2008-07-09
Posted: 2008-09-21
Terminated: 2008-11-03
Recalling firm: Merit Medical Systems, Inc.
Product: 12ml Control Syringe, REF/CAT No.: CCS601 Version B, Sterile R, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty.
Product code: FMF Syringe, Piston
Reason for recall: Control Syringes may be non-sterile due to holes in the packaging.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 679 units
Distribution: CA, FL, GA, ID, IL, IN, KS, LA, MO, MT, OH, PA, TN, and WA. Foreign distribution to Japan.
Product codes and lots: Lot Number: F620653

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)