GMAX SYR 3ML/LL syringes (model TS2203L-M) without needles may not be safe for medical use due to incorrect device clearance. Affected units include specific lot codes from 2023.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 3ML/LL syringes (model TS2203L-M) without needles are being recalled because they may not meet medical device safety standards. Using these syringes could lead to incorrect medical procedures if they don't match the intended device clearance.
These syringes may not be compatible with medical devices cleared by the manufacturer. If used incorrectly, they could cause improper medical procedures due to mismatched device specifications.
Healthcare professionals and patients who use these syringes for medical procedures. Those using the syringes for non-sterile applications are less at risk.
Check for the model number TS2203L-M on the syringe. Look for lot codes starting with SL21030101 through SL23120401. These syringes are non-sterile and without needles.
Identify the model number TS2203L-M on the syringe to confirm it is affected.
Check for lot codes starting with SL21030101 through SL23120401 to determine if the syringe is part of the recall.
The recall states these syringes may not be safe for medical use due to incorrect device clearance. They are non-sterile and without needles.
Check the model number and lot code to see if they are affected. If they are, contact the manufacturer for guidance.
The recall indicates a risk of incorrect medical procedures if the syringes are used improperly, but the hazard is not severe enough to require immediate stop-use.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2108-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2108-2024 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.
