Z-0048-05

8 ml Inject8 Coronary Control Syringe, sterile

Name: Z-0048-05 8 ml Inject8 Coronary Control Syringe, sterile
Creator: Merit Medical Systems, Inc
Published: 2004-09-14
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2004-09-14 / Terminated

FDA source

Merit Medical Systems, Inc began a recall of 8 ml Inject8 Coronary Control Syringe, sterile on 2004-09-14. The reason FDA records is "Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0048-05
Status: Terminated
Initiated: 2004-09-14
Posted: 2004-10-28
Terminated: 2005-03-31
Recalling firm: Merit Medical Systems, Inc.
Product: 8 ml Inject8 Coronary Control Syringe, sterile.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
FDA root cause: Other
Action: All consignees were notified by telephone and letter on 9/14/2004. A second letter, dated 11/24/04, was also sent to consignees.
Quantity in commerce: 11, 332 syringes
Distribution: Nationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands.
Product codes and lots: Product Number CCS880, Lot numbers A333586, A337519, A341381, A337458, A341399.

Product code DXT

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)