Recalls / —

—#35207

Product

8 ml Inject8 Coronary Control Syringe, sterile.

FDA product code

DXT — Injector And Syringe, Angiographic

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K875196

Affected lot / code info

Product Number CCS880, Lot numbers A333586, A337519, A341381, A337458, A341399.

Why it was recalled

Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.

Root cause (FDA determination)

Other

Action the firm took

All consignees were notified by telephone and letter on 9/14/2004. A second letter, dated 11/24/04, was also sent to consignees.

Recalling firm

Firm

Merit Medical Systems, Inc

Address

1600 Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern

Nationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands.

Timeline

Recall initiated

2004-09-14

Posted by FDA

2004-10-28

Terminated

2005-03-31

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #35207. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.