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SOL-M Syringe recallZ-3078-2024 · Sol-Millennium Medical Inc. · initiated May 9, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Sol-Millennium Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Other

What the company is doing

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."

Recall details

Recall number
Z-3078-2024
Status
Open, Classified
Initiated by the company
May 9, 2024
Posted by the FDA
Sep 6, 2024
Recalling firm
Sol-Millennium Medical Inc.
Product code
FMF
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 description

Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low dead space), Model No. 181023L, UPC Sold in Canada Only; d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8" low dead space), Model No. 12558LDS, UPC 810062435319; e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165; f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

a) Model No. 180011LDS, UPC 840368511899, Lot Numbers: 1102070, 1107062, 2002005, 2006004, 2012008, 2909022, 2911053, 19052401; b) Model No. P180011LDS, UPC 810018097554, Lot Numbers: 4104025, 4104100, 4108014, 4108015, 4108017, 4108095, 4109088, 4202001, 4301003, 4303047, 4312032; c) Model No. 181023L, UPC Sold in Canada Only, Lot Numbers: 4301029; d) Model No. 12558LDS, UPC 810062435319, Lot Numbers: 7210016; e) Model No. P180001PP, UPC 818392018165, Lot Numbers: 4104027, 4104028, 4104029, 4104030, 4104031, 4104032, 4105038, 4106031, 4106032, 4106033, 4106074, 4106075, 4106079, 4106080, 4106081, 4106082, 4106083, 4106086, 8103004, 8104004, 8104006, 8104007, 8104008, 8105038, 8105047, 8105053, 8105054, 8106011, 8106014, 8106024, 8106025, 8106026, 8106027, 8106028, 8106029, 8106030, 8106031, 8106032, 8106033; f) Model No. 181025S, UPC NONE, Lot Numbers: 4110059, 4110091, 4110092, 4212021, 4303009, 4303010, 4303011, 4303012, 4304016,

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94968).

Sources and updates

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