FDA Recall Open, Classified

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 · Initiated May 19, 2025

Recall

Recall Number
Z-2100-2025
Event Number
96956
Firm
Neurovision Medical Products Inc
FEI Number
1930870
Product Code
ETN
Status
Open, Classified
Root Cause
Process control
Initiated
May 19, 2025
Posted
July 9, 2025
Address
353 San Jon Rd, Ventura, CA, 93001-3250

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.

Action

On May 20, 2025, Neurovision Medical Products (NMP) sent consignees an email notifying them of the recall. On June 10, 2025, NMP followed up with "Urgent Medical Device Recall Notice" dated May 27, 2025, via US postal mail. Neurovision asked consignees to take the following actions: 1. Review your inventory for affected lots. 2. Quarantine product. 3. Cease distribution and use of any affected product. 4. Pass this notice on to all who need to be aware within your organization and/or to any organization where the potentially affected product has been transferred or distributed. 5. Complete and return the enclosed response form as soon as possible via email: [email protected] or Fax to: (877) 330-1727. 6. NMP Customer Service will respond with a return authorization (RMA) number and return shipping label for any remaining stock. 7. If you have distributed this product to another location or entity, notify them of this product recall (include a copy of this notice), and contact NMP Customer Service for return authorization (RMA). If you have any questions, contact NMP Customer service at (866) 815-6999. NMP Days/Hours Available: Monday through Friday, 8am-4pm (Pacific) and Website: neurovisionmedical.com

Distribution

US distribution to CA only

Quantity

10