—#151906

Product

PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K140543
Affected lot / code info: Lots: H1014678, H1039272, H1029150, H1039269, H1029151

Why it was recalled

Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.

Root cause (FDA determination)

Process change control

Action the firm took

Merit Medical sent an Urgent Product Recall Notice dated December 1, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify any affected devices within their facility, quarantine them, and discontinue use. Ensure that all personnel to whom the devices were distributed are made aware of this field action. Consignees were asked to work with their Merit Sales Representative to arrange product return. Consignees with questions were instructed to contact their Merit Sales Representative or Merit Customer Service at response@merit.com or at 801-208-4381. For questions regarding this recall call 801-208-4623.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2016-12-01
Posted by FDA: 2017-01-05
Terminated: 2017-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151906. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.