GMAX SYR 6ML/LL syringes (model TS2206L-M) with non-sterile design may not meet device clearance standards. Affected units include specific lot codes from 2023. Consumers should check their syringes for lot codes 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 6ML/LL syringes (model TS2206L-M) are being recalled because their piston sizes and configurations don't match the medical devices cleared by the manufacturer. This could lead to improper use in medical settings, potentially causing injury or ineffective treatment.
The syringes have piston sizes and configurations that don't align with the medical devices cleared by the manufacturer. This mismatch could result in improper use during medical procedures, potentially causing injury or ineffective treatment.
Healthcare professionals and individuals using these syringes for medical purposes may be affected. Those using the syringes for non-sterile applications are at higher risk due to the non-sterile design.
Check for the model number TS2206L-M and lot codes SL22070104, SL22100203, SL23080303, SL23100403, or SL23120403. These syringes are non-sterile and designed for single use without needles.
Look for lot codes SL22070104, SL22100203, SL23080303, SL23100403, or SL23120403 on the syringe packaging.
The recall indicates these syringes may not meet device clearance standards, so they are not recommended for medical use.
Check the lot code on your syringe packaging. If it matches the listed lot codes, contact the manufacturer for further instructions.
The syringes have piston sizes and configurations that don't align with the medical devices cleared by the manufacturer.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2110-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2110-2024 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.
