Class 2 Device Recall SOLM

• Date Initiated by Firm: May 09, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3079-2024
• Recall Event ID: 94968
• Product Classification: Container, liquid medication, graduated - Product Code KYW
• Product: Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A
• Code Information: 1) Model No. STCB01, UPC N/A, LOT NUMBERS: 4201063, 4209005, 4307016, 4308061, 4311036; 2) Model No. STCB02, UPC N/A, LOT NUMBERS: 4201064; 3) Model No. 110101150020, UPC N/A LOT NUMBERS: EXPIRED 4) Model No. STCT01, UPC: Sole in Canada only, LOT NUMBERS: 4301023, 4308072, 4308073, 4309043, 4310029, 04311037, 4312011, 4312093, 4402006
• Recalling Firm/ Manufacturer: Sol-Millennium Medical Inc.; 311 S Wacker Dr; Chicago IL 60606-6604
• For Additional Information Contact: Peter Ren; 312-545-8025
• Manufacturer Reason for Recall: Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
• FDA Determined Cause: Other
• Action: Sol M issued a Voluntary Recall Action Letter to Distributors to its consignees on 05/09/2024 via email. The notice explained the reason for the recall and requested the following: "ACTIONS REQUIRED: 1. Examine your inventory and quarantine the affected product codes and lots subject to this recall action. 2. Distributors, please identify your customers, and notify them at once of this recall action to the distributor level. Such notification may be enhanced by including the enclosed letter (Appendix B) for your customers and Healthcare Providers (HCP s) in the field. 3. Return the enclosed Appendix B with the information via email to recalls@sol-m.com. The quarantine should be carried out to the wholesale and distributor level. Products in the field beyond the control of the distributor or wholesaler should be recalled from the field and returned to the distributor. Distributors should quarantine the products in inventory and quarantine the products received from customers until the 510(k) submissions are pending or cleared. The returned product should be quarantined in a secure location to avoid distribution based on your quality management procedures. We will provide communication with any updates as we work with the FDA."
• Distribution: US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, Panama
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.