GMAX SYR 30ML/LL syringes (model TS2230L-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 30ML/LL syringes (model TS2230L-M) are recalled because they don't meet medical device clearance standards. Using them could lead to incorrect medical treatments if they're not properly sized for the intended use.
These syringes have sizes and configurations that don't match the medical devices cleared by the manufacturer. This means they might not work correctly for medical procedures, potentially leading to incorrect dosing or treatment.
Users of these syringes for medical purposes, particularly those who may have purchased them without needles for single use. The risk is low for most users since the syringes are non-sterile and intended for single use.
Check for the model number TS2230L-M on the syringe. The syringes are non-sterile and without needles, intended for single use. They were sold with lot codes starting with SL21030107 through SL23120408.
Look for the model number TS2230L-M and lot codes starting with SL21030107 through SL23120408 on the syringe.
No, these syringes have sizes and configurations that don't match the medical devices cleared by the manufacturer, so they may not be safe for intended use.
Check the model number and lot codes to see if your syringes are affected. If they are, you should stop using them and contact the manufacturer for further instructions.
No, these syringes are non-sterile and intended for single use without needles.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2114-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2114-2024 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.
