Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use fiber K2011828 400 micron 5X reusable fiber K1010500 600 micron fibertome fiber K2012021 600 micron single use fiber K1015640 AngioSpot Fiber Kit K2012393 600 micron single use fiber K2010292 400 micron single use fiber K20124
Hazard
Pin hole package failures compromising sterility of product
What You Should Do
Remedy
Dornier MedTech America notified customers by telephone and follow-up by letter sent Certiied Mail on 4-10-19. Accounts advised of problem, health risk and action to take: The customer should immediately quarantine all inventory of Dornier Diode Laser Fibers and return all product to Dornier per the provided instructions. Contact the Dornier Quality Department at 1-800-367-6437
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Products
Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers
Part Number/Description:
K1001291 600 micron single use fiber
K2011824 600 micron single use fiber
K1001293 600 micron single use f
- Brand
- Dornier Medtech America, Inc.
- UPC
- All lot numbers
Units Affected
400 units