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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1967-2021 - 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.
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2
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06/25/2021
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FEI # 3011534533 Spes Medica
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Z-1968-2021 - SNS 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...
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2
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06/25/2021
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FEI # 3011534533 Spes Medica
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Z-1971-2021 - Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
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2
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06/25/2021
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FEI # 3011534533 Spes Medica
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Z-1970-2021 - SNS 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...
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2
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06/25/2021
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FEI # 3011534533 Spes Medica
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Z-1969-2021 - Dragonfly 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.
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2
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06/25/2021
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FEI # 3011534533 Spes Medica
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