Recall Z-0345-06 ยท DYB Introducer, Catheter
Oscor Inc.
Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant)
| Date | Jan 6, 2006 (initiated Sep 13, 2005) |
| Status | Terminated |
| Reason | Sheath size is larger than dilator size causing insertion difficulties. |
| Root cause | Other |
| Action | The firm will issue a recall letter to its consignees informing them of the recall. The letter will ask the consignees to return the devices from affected lot numbers for replacement. The returned products will be individually inspected. |
| Quantity | 6985 |
| Distribution | Distributed throughout the United States and to several foreign countries including China, Japan, Germany and the Phillippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K871153 | CATHETER INTRODUCER Angeion Corp., Jun 24, 1987 |