GMAX SYR 60ML/LL syringes (model TS2260L-M) without needles are recalled due to incorrect device clearance. These non-sterile syringes may not meet safety standards for medical use.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 60ML/LL syringes (model TS226:0L-M) without needles are being recalled because they do not meet the required safety standards for medical use. This could lead to incorrect dosing or medical complications if used improperly.
The syringes have sizes and configurations that do not match the medical devices cleared by the manufacturer. This mismatch could lead to incorrect dosing or medical complications if used improperly.
Healthcare professionals and patients who have purchased these non-sterile syringes for medical use are affected. Those using them for injections without proper medical supervision are at higher risk.
Check for the model number TS2260L-M on the syringe packaging. These non-sterile syringes without needles were sold with lot codes starting with SL21030108 through SL23120410.
Verify the model number on the syringe is TS2260L-M to confirm it is part of this recall.
No, these non-sterile syringes have sizes and configurations that do not meet medical safety standards and should not be used.
Check the model number and lot code to see if they are part of this recall. If they are, stop using them and contact the manufacturer for guidance.
Look for the model number TS2260L-M and lot codes starting with SL21030108 through SL23120410 on the packaging.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2116-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2116-2024 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.
