GMAX SYR 20ML/LL syringes (model TS2220L-M) without needles are recalled due to incorrect medical device clearance. These non-sterile syringes may not be safe for use as intended.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 20ML/LL syringes (model TS2220L-M) are recalled because they don't meet the medical device clearance standards. Using these syringes could lead to incorrect medical procedures if they're not properly sized for the intended use.
The syringes have sizes and configurations that don't match the medical devices cleared by the manufacturer. This means they might not work correctly for intended medical procedures, potentially causing incorrect dosing or procedure failure.
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 TS2220L-M on the syringe. These non-sterile syringes without needles were sold with lot codes including SL21030106 through SL23120407.
Look for the model number TS2220L-M on the syringe to confirm if it's affected.
The recall indicates these syringes may not be safe for medical use due to incorrect device clearance. They should not be used for medical procedures.
The recall record does not specify a remedy, so contact the manufacturer for guidance on safe disposal or alternatives.
Check for the model number TS2220L-M and lot codes listed in the recall (e.g., SL21030106 through SL23120407).
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2113-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2113-2024 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.
