GMAX SYR 12ML/LL syringes (model TS2212L-M) without needles are recalled due to being unapproved for medical use. These non-sterile syringes may not be safe for medical procedures.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 12ML/:LL syringes (model TS2212L-M) are recalled because they were not approved for medical use. Using these syringes could lead to unsafe medical procedures since they don't meet regulatory standards.
These syringes were not cleared by the manufacturer's regulatory process for medical use. They may not function properly or be safe when used for injections, potentially causing injury or infection.
Users of these syringes for medical procedures are affected. Healthcare professionals and patients using non-sterile syringes for injections may be at risk.
Check for the model number TS2212L-M on the syringe. Look for lot codes: SL22070107, SL22100203, SL23080303, SL23100403, or SL23120406.
Identify the model number on the syringe to confirm it matches TS2212L-M.
Check for lot codes SL22070107, SL22100203, SL23080303, SL23100403, or SL23120406.
No, these syringes were not approved for medical use and may not be safe for injections.
The recall does not specify a remedy, so contact the manufacturer for guidance.
Look for the model number TS2212L-M and lot codes SL22070107, SL22100203, SL23080303, SL23100403, or SL23120406.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2112-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2112-2024 from GMAX. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
