Recalls / —

—#27559

Product

Inject 10 Coronary Control Syringe (CCS), 10ml

FDA product code

FMF — Syringe, Piston

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K875196

Affected lot / code info

REF/CAT No.: CCX010, Lot No''s. A257336, A258248, A258893, A263340.

Why it was recalled

Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.

Root cause (FDA determination)

Other

Action the firm took

On 5/16/2003, all distributors and consignees were notified by letter.

Recalling firm

Firm

Merit Medical Systems, Inc

Address

1600 West Merit Parkway, South Jordan, Utah 84095

Distribution

Distribution pattern

Nationwide. Foreign distribution to France, Malaysia, Taiwan, Dominican Republic.

Timeline

Recall initiated

2003-05-16

Posted by FDA

2003-06-05

Terminated

2003-07-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27559. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.