Z-3079-2024Class II

Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip...

Name: Z-3079-2024 Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip...
Creator: Sol-Millennium Medical Inc.
Published: 2024-05-09
License: https://open.fda.gov/license/

Sol-Millennium Medical, Inc. / initiated 2024-05-09 / Open, Classified

FDA source

Sol-Millennium Medical Inc. began a recall of 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... on 2024-05-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3079-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-09
Posted: 2024-09-06
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
Product code: KYW Container, Liquid Medication, Graduated
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 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 [email protected]. 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3079-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3074-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06
Z-3075-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06
Z-3076-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06
Z-3077-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06
Z-3078-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06
Z-3079-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06

Product code KYW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)