Recalls / —

—#52160

Product

Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah.

FDA product code

FMG — Stopcock, I.V. Set

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K915678

Affected lot / code info

Lot number V536479.

Why it was recalled

Male luer in fluid administration sets may crack due to inadequate molding process

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product.

Recalling firm

Firm

Merit Medical Systems, Inc.

Address

1600 Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern

CA, IL, NJ, NY. No military, government or foreign distribution.

Timeline

Recall initiated

2007-04-17

Posted by FDA

2007-05-31

Terminated

2008-05-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #52160. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.