FDAClass IIMay 22, 2013

Loop, Cutting, 24FR recall: Contamination

Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Why was Loop, Cutting, 24FR recalled?

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

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 36781

Product
Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Recalling firm
Karl Storz Endoscopy America Inc
Quantity
9432 units
Distribution
Distributed Nationwide and in Canada.
Recall date
May 22, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls