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Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF:… recallZ-0992-2007 · Ev3, Inc · initiated May 18, 2007

Terminated All recalls posted in July 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 Ev3, 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

Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr.

FDA root cause category: Other

What the company is doing

Letter May 18, 2007.

Recall details

Recall number
Z-0992-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 18, 2007
Posted by the FDA
Jul 11, 2007
Recalling firm
Ev3, Inc
Quantity
23 units
Product code
DXE
FDA submissions
K972511
Distribution
Worldwide, including USA, Belgium, France, Germany, Italy, Jordan, Spain, United Kingdom, and Yemen.

Product description

Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE ENDOVASCULAR COMPANY. The Snare Kit contains a pouch labeled a "Snare Catheter" and a pouch labeled "Amplatz Goose Neck Snare". Snare Catheter

Code information (models, lots, serial numbers)

Lot # 1650307

Other devices under the same FDA submission

12 devices cleared under K972511 — 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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