Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South Jordan, Utah. In

FDA device recall Z-0941-2011 · posted 2011-01-28 · Terminated

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

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

Action taken

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.

Root cause

Component change control

Status

Terminated

Product code

DYB

Quantity affected

378 units

Distribution

Nationwide Distribution

Date initiated

2010-12-17

Date posted

2011-01-28

Date terminated

2011-07-11

Location

South Jordan, UT

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