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Z-2719-2024 Class II Ongoing

Recalled by Neurovision Medical Products Inc — Ventura, CA

FDA device recall Z-2719-2024 was initiated by Neurovision Medical Products Inc on Jul 1, 2024 and is designated Class II. Reason for recall: mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. The recall status is ongoing. Affected quantity: 5 BOXES (25 single kits).

Recall Details

Product Type: Devices
Report Date: Sep 4, 2024
Initiation Date: Jul 1, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5 BOXES (25 single kits)

Product Description

Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO

Reason for Recall

mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.

Distribution Pattern

US Nationwide distribution.

Code Information

LOT: 051724B/ UDI: B006LTE7003PS52

Other recalls by Neurovision Medical Products Inc

Z-2100-2025 Class II — Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - M (May 19, 2025)
Z-2900-2020 Class II — Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6- (Jul 21, 2020)
Z-2905-2020 Class II — Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B00 (Jul 21, 2020)
Z-2904-2020 Class II — Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B00 (Jul 21, 2020)
Z-2907-2020 Class II — Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B (Jul 21, 2020)
Z-2901-2020 Class II — Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C (Jul 21, 2020)
Z-2903-2020 Class II — Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B00 (Jul 21, 2020)
Z-2906-2020 Class II — Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B (Jul 21, 2020)
Z-2902-2020 Class II — Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C (Jul 21, 2020)
Z-2908-2020 Class II — Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B (Jul 21, 2020)