Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away sheath with b
FDA device recall Z-1443-05 · posted 2005-08-30 · Terminated
Recall details
- Recalling firm
- Guidant Corporation
- Reason for recall
- A manufacturer of Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 19, 815
- Distribution
- nationwide and worldwide.
- Date initiated
- 2005-06-13
- Date posted
- 2005-08-30
- Date terminated
- 2007-01-05
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEAD INTRODUCER SETS-EB-S8 & EB-S12 (K831751) | Oscor, Inc. | 1983-10-20 |