—#96488

Product

Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South Jordan, Utah. Intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. Can also provide access to a native or synthetic graft used for hemodialysis.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K082063
Affected lot / code info: Lot Number: H179575

Why it was recalled

Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response.

Root cause (FDA determination)

Component change control

Action the firm took

Merit Medical Systems, Inc., issued an "Urgent Product Recall Notice" dated December 17, 2010, and contacted all customers (sales reps and authorized distributors) via email, phone and/or fax. The notice described the product, problem and action to be taken by the customers (Sales reps/Distributors). The customers were instructed to contact all their customers to identify, quarantine and return all unused inventory and extend the recall to any of their customers who may have received the affected products. The customers were instructed to complete and return the Manufacturer RECALL NOTIFICATION and Product Retrieval Form via fax to 1-801-208-3378 and send original to: the Manager, Customer Service, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, UT 84095-2416. Questions should be directed to the Senior Product Manager at 801-208-4344 or the Manager, Customer Service at 801-208-4365.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 West Merit Parkway, South Jordan, Utah 84095

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2010-12-17
Posted by FDA: 2011-01-28
Terminated: 2011-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96488. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.