FDA Enforcement
Class II
Ongoing
Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation Probe, 90mm, and 1 Green Ground Needle ; REF 1-D-BMF90-5, lot number 050925219, expiration 2028-11-30 I-D-BMF90-5 Stimulated EMG Kit with Hummingbird - Box of 5 Kits - Each Kit Includes: 1 Single-Use Bipolar Minifork Stimuation Probe, 90mm, and 1 Green Ground Needle
Recall: Z-2100-2025
·
Reported July 16, 2025
Enforcement
- Recall Number
- Z-2100-2025
- Event ID
- 96956
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Neurovision Medical Products Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- July 16, 2025
- Initiation Date
- May 19, 2025
- Classification Date
- July 9, 2025
- Address
- 353 San Jon Rd, N/A, Ventura, CA, 93001-3250, United States
Description
Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation Probe, 90mm, and 1 Green Ground Needle ; REF 1-D-BMF90-5, lot number 050925219, expiration 2028-11-30 I-D-BMF90-5 Stimulated EMG Kit with Hummingbird - Box of 5 Kits - Each Kit Includes: 1 Single-Use Bipolar Minifork Stimuation Probe, 90mm, and 1 Green Ground Needle
Reason
Product packaging contains the wrong part number and kit contents.
Code Info
REF I-D-BMF90 & 1-D-BMF90-5, lot number: 050925219
Distribution
US distribution to CA only
Quantity
10