GMAX SYR 10ML Control syringes (model TS3210L-M) may not be compatible with medical devices due to incorrect size configurations. Affected units include specific lot codes from 2021-2023. Consumers should 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 10ML Control syringes (model TS3210L-M) are being recalled because their piston sizes don't match medical devices approved by the FDA. This could lead to incorrect medical use if used with devices cleared for different syringe sizes.
The syringes have piston sizes and configurations that don't match the medical devices cleared by the FDA. This mismatch could cause incorrect medical use, potentially leading to treatment errors or complications.
Medical users who purchased these syringes from 2021 to 2023 are likely affected. Patients using these syringes for medical procedures may be at risk if the syringes are incompatible with their devices.
Check for the model number TS3210L-M on the syringe. Affected units include specific lot codes: SL21040108 through SL23120411, sold between 2021 and 2023.
Identify the model number TS3210L-M on the syringe to confirm if it is affected.
Reach out to Jiangsu Shenli Medical Production Co., Ltd. for specific instructions on handling affected units.
The recall indicates the syringes may not be compatible with medical devices cleared by the FDA, so they should not be used without confirmation from the manufacturer.
Affected lot codes range from SL21040108 to SL23120411, sold between 2021 and 2023.
Check for the model number TS3210L-M and the specific lot codes listed in the recall notice.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2121-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2121-2024 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.
