FDA Medical Device Recalls (openFDA)
Oscor, Inc.: Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.
- Recall number
- Z-0130-2009
- Recalling firm
- Oscor, Inc.
- Product
- Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.
- Status
- Terminated
- Initiated
- 2008-07-03
- Posted
- 2008-10-29
- Terminated
- 2008-12-09
- 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.
- Lot, serial or model codes
- Lot Numbers: C1-02452, C1-02453, C1-02452, C1-02458, C1-02462.
- 510(k) numbers
- ["K073100"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1035166
- Firm city
- Palm Harbor
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28