GMAX SYR 20ML/LS syringes (model TS2220S-M) with non-sterile design may not meet device clearance standards. Affected units include specific lot codes from production batches. Consumers should check their syringes for lot numbers and contact the manufacturer for details.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 20ML/LS syringes (model TS2220S-M) are being recalled because they may not meet the required device clearance standards. This could lead to improper use if the syringes are used for medical purposes without proper validation.
The syringes may not meet the device clearance standards intended by the manufacturer, which could result in improper use if used for medical purposes without proper validation. This is a regulatory issue rather than a direct safety hazard.
Users of GMAX SYR 20ML/LS syringes with lot codes listed in the recall notice are affected. Healthcare professionals and individuals using these syringes for medical purposes are at the highest risk.
Check the syringe for the model number TS2220S-M and lot codes such as SL21030110, SL21040106, and others listed in the recall notice. These syringes are non-sterile and designed for single use without needles.
Look for lot codes like SL21030110, SL21040106, or others listed in the recall notice on the syringe packaging.
The recall states these syringes may not meet device clearance standards, so they are not recommended for medical use without proper validation.
Check the lot number on the syringe packaging and contact the manufacturer for further instructions.
The recall indicates potential regulatory non-compliance, but no specific injury risks are mentioned in the official notice.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2119-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2119-2024 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.
