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Flexxus™ Endoscopic Biliary Stent, 7.5 Fr recallZ-0730-2007 · Conmed Endoscopic Technologies, Inc. · initiated Mar 14, 2007

Terminated All recalls posted in April 2007

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 Conmed Endoscopic Technologies, 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

Blue safety clip incorrectly placed on the stent may prevent deployment

FDA root cause category: Other

What the company is doing

ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.

Recall details

Recall number
Z-0730-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 14, 2007
Posted by the FDA
Apr 11, 2007
Recalling firm
Conmed Endoscopic Technologies, Inc.
Quantity
1 UNIT
Product code
FGE
FDA submissions
K031186
Distribution
Worldwide distribution, USA including states of DE, OH, MI, DC and countries of Belgium Japan.

Product description

Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10 mm diameter x 60 mm length Item Number: LXB10060

Code information (models, lots, serial numbers)

Lot Number: ANQJ0639

Other devices under the same FDA submission

2 devices cleared under K031186 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 37628).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page