Recall Z-1913-2009 ยท DYB Introducer, Catheter
Edwards Lifesciences, Llc
Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion.
| Date | Aug 25, 2009 (initiated May 11, 2009) |
| Status | Terminated |
| Reason | Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use. |
| Root cause | Nonconforming Material/Component |
| Action | Edwards LifeSciences LLC initiated the worldwide recall via customer letters dated May 11, 2009 and are being sent by Federal Express stating that customers cease using affected product from the indicated lots and return all unused products. The firm requested that the customer provide written verification of stock and identify any unused product to be returned. For further information, contact Edwards LifeSciences LLC Customer Service at 1-800-424-3278. |
| Quantity | 67,357 Units |
| Distribution | Worldwide Distribution: United States (AL, AR, CA, CO, CT, DC, FL, GA, IA, IL, IN,KS, KY, MA, MD, ME, MI, MO, MS, ND, NH, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, VA, WV, HI and PR), Austria, Canada, Switzerland, Czech,republic, Germany, Denmark, Algeria, Estonia, Egypt, Spain, Finland, France, Great |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981909 | BAXTER HEMOSTASIS VALVE INTRODUCERS Baxter Edwards, Nov 24, 1998 |