Cypress Medical Products LLC: Device Recall

Recall #Z-3184-2024 · 08/20/2024

Class II: Risk

Recall Details

Recall Number: Z-3184-2024
Classification: Class II
Product Type: Device
Recalling Firm: Cypress Medical Products LLC
Status: Ongoing
Date Initiated: 08/20/2024
Location: Richmond, VA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15 kits

Reason for Recall

Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.

Product Description

BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025

Distribution Pattern

US Nationwide distribution.

Other Recalls by Cypress Medical Products LLC

Class II: Risk 08/20/2024

Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Class II: Risk 08/06/2024

The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.
Class II: Risk 07/24/2024

Affected syringes lack FDA clearance.

View all recalls by Cypress Medical Products LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.