GMAX SYR 10ML/LL Blue syringes (model TS221:0B-M) may not be compatible with medical devices due to incorrect size configurations. Affected units were sold with lot codes SL23040204 and SL23020211. Consumers should check their syringes and contact the manufacturer for guidance.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 10ML/LL Blue syringes with model number TS2210B-M were recalled because their size and configuration don't match medical devices approved by the FDA. This could lead to incorrect medical use if used with devices cleared under the manufacturer's 510(k) process.
The syringes' size and configuration fall outside the range of devices cleared under the manufacturer's 510(k) process. This mismatch could result in incorrect medical use if the syringes are used with devices that require specific compatibility.
Users of GMAX SYR 10ML/LL Blue syringes with model TS2210B-M, particularly those in medical settings that require precise syringe compatibility. Patients using these syringes for medical procedures may be at risk if the syringes are used with devices not designed for them.
Check for the model number TS2210B-M on the syringe. Affected units have lot codes SL23040204 or SL23020211. The syringes are non-sterile and designed for single use without needles.
Look for the model number TS2210B-M on the syringe to confirm if it is affected.
The recall indicates the syringes may not be compatible with medical devices cleared under the manufacturer's 510(k) process, so they should not be used for medical procedures without consulting the manufacturer.
The recall does not specify a remedy, so contact the manufacturer directly for guidance on handling affected units.
Yes, affected units have lot codes SL23040204 or SL23020211.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2122-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2122-2024 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.
