Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.
FDA device recall Z-0130-2009 · posted 2008-10-29 · Terminated
Recall details
- Recalling firm
- Oscor, Inc.
- Reason for recall
- Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.
- Action taken
- Oscor notified the Direct Account by letter on 07/03/2008. Direct account was asked to return all unused Introducers back to Oscor. All returned products should be labeled with the Return Goods Product number.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 396
- Distribution
- Product was distributed to one direct account in MN.
- Date initiated
- 2008-07-03
- Date posted
- 2008-10-29
- Date terminated
- 2008-12-09
- 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 |
|---|---|---|
| INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S (K073100) | Oscor, Inc. | 2007-11-30 |