FDAClass IIMay 29, 2019

Dornier Diode Laser Fibers:Used with Dornier Medilas D recall: Sterility Concern

Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron…

Why was Dornier Diode Laser Fibers:Used with Dornier Medilas D recalled?

Pin hole package failures compromising sterility of product

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?

All lot numbers

Product
Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron…
Recalling firm
Dornier Medtech America, Inc.
Quantity
400 units
Distribution
US Nationwide distribution.
Recall date
May 29, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls