FDAClass IIJanuary 16, 2013

Laparoscope recall

Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a…

Why was Laparoscope recalled?

Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 1179107

Product
Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a…
Recalling firm
Applied Medical Resources Corp
Quantity
72 units
Distribution
Worldwide Distribution - USA (nationwide) and France.
Recall date
January 16, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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