FDA Device

Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.

Hazard

Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.

What You Should Do

Remedy

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.

Products

Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.
Brand
Oscor, Inc.
UPC
Lot Numbers: C1-02452, C1-02453, C1-02452, C1-02458, C1-02462.

Units Affected

396