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LigaSure Atlas Laparoscopic Vessel Sealer/Divider recallZ-0772-06 · Covidien LP · initiated Jan 27, 2006

Terminated All recalls posted in April 2006

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 Covidien LP 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

Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.

FDA root cause category: Other

What the company is doing

Consignees were notified by letter on 01/27/2006.

Recall details

Recall number
Z-0772-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 27, 2006
Posted by the FDA
Apr 19, 2006
Recalling firm
Covidien LP
Quantity
124,000 units domestic, 126,000 units internationally.
Product code
GEI
FDA submissions
K010013
Distribution
Nationwide, including 52 VA facilities and 12 military facilities. Foreign distribution to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatamala, Israel, Japan, Mexico, Paraguay, Peru, Singapore, South Africa, Uruguay, Venezuela.

Product description

LigaSure Atlas Laparoscopic Vessel Sealer/Divider

Code information (models, lots, serial numbers)

Catalog Number LS1100. Lot Numbers: Any lot number beginning with U, N2, N3, N4, or N5A through N5L247K.

Other devices under the same FDA submission

2 devices cleared under K010013 — 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 34573).

Sources and updates

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