Recall Z-1381-2019 ยท GEX Powered Laser Surgical Instrument
Dornier Medtech America, Inc.
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
| Date | Apr 1, 2019 |
| Status | Terminated |
| Reason | Pin hole package failures compromising sterility of product |
| Root cause | Package design/selection |
| Action | 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 |
| Quantity | 400 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083500 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE Dornier Medtech America, Inc., Feb 12, 2009 |