FDAApril 8, 2021device
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
What to do
FDA enforcement status: Terminated
Brands named
spes medicaspes
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMedica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.2025-12-31
- FDAQuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 2002021-09-22
- FDATripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.2021-04-08
- FDADragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.2021-04-08
- FDASNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE0062021-04-08
- FDASNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE0022021-04-08
- FDAMedica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.2019-02-06
- FDAWash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The m...2017-11-21
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