Recall Z-0130-2009 ยท DYB Introducer, Catheter
Oscor, Inc.
Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.
| Date | Oct 29, 2008 (initiated Jul 3, 2008) |
| Status | Terminated |
| Reason | Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 396 |
| Distribution | Product was distributed to one direct account in MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073100 | INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S Oscor, Inc., Nov 30, 2007 |