Recall Z-0941-2011 ยท DYB Introducer, Catheter
Merit Medical Systems, Inc.
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.
| Date | Jan 28, 2011 (initiated Dec 17, 2010) |
| Status | Terminated |
| Reason | Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response. |
| Root cause | Component change control |
| Action | 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 NOTIFICATI |
| Quantity | 378 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082063 | PRELUDE SHORT SHEATH INTRODUCER Merit Medical Systems, Inc., Oct 15, 2008 |