| | Class 2 Device Recall SOLM standard slip tip syringe without needle |  |
| Date Initiated by Firm | May 09, 2024 |
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| Date Posted | September 06, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3076-2024 |
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| Recall Event ID |
94968 |
| Product Classification |
Syringe, piston - Product Code FMF
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| Product | Syringes with Luer Slip Tips labeled as:
1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138;
2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523;
3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998;
4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493;
5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462;
6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646;
7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636;
8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333;
9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340;
10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957 |
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| Code Information |
1) Model No. 180011, UPC 8183923010138, Lot Numbers: 19072506;
2) Model No. P180011, UPC 810018097523, Lot Numbers: 4107175, 4107176, 4110015, 4312056;
3) Model No. 180020ST, UPC 840368511998, Lot Numbers: 4209011;
4) Model No. P180003ST, UPC 810018097493, Lot Numbers: 4105121;
5) Model No. P180005ST, UPC 810018097462, Lot Numbers: 4104054;
6) Model No. P180010ST, UPC 810018097646, Lot Numbers: 4105081, 4108076, 4111055, 4302012, 4303050;
7) Model No. P180020ST, UPC 810018098636, Lot Numbers: 4110014, 4110055, 4301004, 4303048;
8) Model No. P180030ST, UPC 810062435333, Lot Numbers: 4302041;
9) Model No. P180060ST, UPC 810062435340, Lot Numbers: 4302042;
10) Model No. P180011T, UPC 810018098957, Lot Numbers: 4108002 |
Recalling Firm/
Manufacturer |
Sol-Millennium Medical Inc.
311 S Wacker Dr
Chicago IL 60606-6604
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| For Additional Information Contact | Peter Ren
312-545-8025 |
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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. |
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FDA Determined
Cause 2 | Other |
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| 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." |
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| 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 |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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