Recall Z-1443-05 ยท DYB Introducer, Catheter
Guidant Corporation
Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away sheath with built-in luer-lock; 1 vessel dilator; 1 50-cm guidewire 1 18-G needle; 1 10-cc syringe. Sterile EO. Manufacturer Oscor Inc. 3816 DeSoto Boulevard, Palm Harbor, FL 34683. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
| Date | Aug 30, 2005 (initiated Jun 13, 2005) |
| Status | Terminated |
| Reason | A manufacturer of Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use. |
| Root cause | Other |
| Action | By Telephone, 6/13/2005. Guidant Sales Reps are to visit hospitals to remove any remaining inventory. Dear Hospital Administrator letter may be left with hospital to explain the removal of product. |
| Quantity | 19, 815 |
| Distribution | nationwide and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831751 | LEAD INTRODUCER SETS-EB-S8 & EB-S12 Oscor, Inc., Oct 20, 1983 |