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Terminated

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

FDA Recall Z-0130-2009 · Posted 2008-10-29

Recalling FirmOscor, Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2008-07-03
Date Terminated2008-12-09
Product Quantity396

Reason for Recall

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

Firm 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.

Root Cause

Process design

Distribution Pattern

Product was distributed to one direct account in MN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K073100INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-SOscor, Inc. · 2007-11-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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