Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.
- Company
- Oscor, Inc.
- Recall Initiated
- July 3, 2008
- Posted
- October 29, 2008
- Terminated
- December 9, 2008
- Recall Number
- Z-0130-2009
- Quantity
- 396
- Firm Location
- Palm Harbor, FL
Reason for Recall
Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.
Distribution
Product was distributed to one direct account in MN.
Lot / Code Info
Lot Numbers: C1-02452, C1-02453, C1-02452, C1-02458, C1-02462.
Root Cause
Process design
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.
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