—#85855

Product

Merit Medical Systems, Inc. Connection Tube label reading in part: CONNECTING TUBE 12" STERILE K10-04129, CATALOG NUMBER K10-04129 Connection tubing can be used with any drainage catheter and drainage bag

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K913682
Affected lot / code info: Lot #: F709636

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 #85855. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.