GMAX SYR 10ML/LL syringes (model TS2210L-M) without needles are recalled due to incorrect medical device clearance. These non-sterile syringes may not be safe for use as intended.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 10ML/LL syringes (model TS2210L-M) are recalled because their piston sizes and configurations don't match the medical devices cleared by the manufacturer. Using these syringes could lead to incorrect medical treatments.
The syringes have piston sizes and configurations that are outside the approved medical device clearance. This means they might not function correctly during medical procedures, potentially causing incorrect dosing or treatment.
Users of these syringes for medical purposes are affected. Healthcare providers and patients using non-sterile syringes for injections may be at risk.
Check for the model number TS2210L-M on the syringe. Look for lot codes like SL21030104, SL21040103, or other listed codes in the product description.
Verify the model number on the syringe is TS2210L-M.
Reach out to Jiangsu Shenli Medical Production Co., Ltd. for further assistance.
The recall states these syringes have piston sizes and configurations outside approved medical device clearance, so they are not safe for intended use.
Check the model number and lot code to confirm if they are recalled. Contact the manufacturer for guidance.
Yes, these syringes may not function correctly during medical procedures, potentially leading to incorrect dosing or treatment.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2111-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2111-2024 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.
