FDA Medical Device Recalls (openFDA)
Sol-Millennium Medical Inc.: 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
- Recall number
- Z-3079-2024
- Recalling firm
- Sol-Millennium Medical Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2024-05-09
- Posted
- 2024-09-06
- Terminated
- not on file
- Reason
- 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.
- Root 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."
- Quantity
- not on file
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYW
- Firm FEI
- 3014312726
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28