Recalls / —

—#85863

Product

Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: TS220

FDA product code

DXT — Injector And Syringe, Angiographic

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K884913

Affected lot / code info

Lot #: D923107

Why it was recalled

Potential sterility breach caused by excessive shipment damage.

Root cause (FDA determination)

Other

Action the firm took

Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.

Recalling firm

Firm

Merit Medical Systems, Inc.

Address

1600 Merit Pkwy South, Jordan, Utah 84095

Distribution

Distribution pattern

US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.

Timeline

Recall initiated

2009-09-29

Posted by FDA

2009-12-14

Terminated

2009-12-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #85863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.