—#34288

Product

Merit MAK Mini Access Kit, 4 French (1.3mm)

FDA product code: DRE — Dilator, Vessel, For Percutaneous Catheterization
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K031691
Affected lot / code info: Catalog Number MAK401N, Lot Numbers: G331723, G338460, M9337635, MR314388, MR317166, MR320063.

Why it was recalled

Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by phone and letter on 7/20/2004.

Recalling firm

Firm: Merit Medical Systems, Inc
Address: 1600 Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: Nationwide, including VA facilities in MA, MI, NY, RI and TX. Argentina, Canada, China, Germany, Italy, Israel, Netherlands, New Zealand, Saudi Arabia, Scotland, Singapore, Thailand, United Arab Emirates.

Timeline

Recall initiated: 2004-07-20
Posted by FDA: 2004-08-04
Terminated: 2005-01-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34288. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.