Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607
FDA device recall Z-0345-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- Oscor Inc.
- Reason for recall
- Sheath size is larger than dilator size causing insertion difficulties.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 6985
- Distribution
- Distributed throughout the United States and to several foreign countries including China, Japan, Germany and the Phillippines.
- Date initiated
- 2005-09-13
- Date posted
- 2006-01-06
- Date terminated
- 2012-07-08
- Location
- Palm Harbor, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CATHETER INTRODUCER (K871153) | Angeion Corp. | 1987-06-24 |