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Oscor Adelante Luer-Lock Peel Away Introducer Set, for… recallZ-0130-2009 · Oscor, Inc. · initiated Jul 3, 2008

Terminated All recalls posted in October 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Oscor, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process design

What the company is doing

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.

Recall details

Recall number
Z-0130-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 3, 2008
Posted by the FDA
Oct 29, 2008
Recalling firm
Oscor, Inc.
Quantity
396
Product code
DYB
FDA submissions
K073100
Distribution
Product was distributed to one direct account in MN.

Product description

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

Code information (models, lots, serial numbers)

Lot Numbers: C1-02452, C1-02453, C1-02452, C1-02458, C1-02462.

Other devices under the same FDA submission

10 devices cleared under K073100 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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