GMAX SYR 35ML/LL syringes (model TS2235L-M) without needles are recalled due to incorrect medical device clearance. Non-sterile syringes may not be safe for medical use.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 35ML/LL syringes (model TS223:35L-M) without needles are recalled because they don't meet medical device clearance standards. Using these syringes for medical purposes could lead to incorrect use and potential health risks.
These syringes were not cleared for medical use by the manufacturer's regulatory process. The device may not function correctly when used for medical injections, leading to potential health risks.
People who own or use these non-sterile syringes for medical purposes are affected. Healthcare providers and patients using these syringes for injections are at risk.
Check for the model number TS2235L-M on the syringe. Look for lot codes SL22070111, SL22100211, or SL23080310. These syringes are non-sterile and without needles.
Identify the model number (TS2235L-M) and lot codes (SL22070111, SL22100211, SL23080310) to confirm if your syringe is recalled.
No, these syringes were not cleared for medical use and may not function correctly, posing a risk of incorrect medical use.
Check the model number and lot codes to see if your syringe is recalled. If it is, stop using it for medical purposes.
The syringes do not meet the medical device clearance standards set by the manufacturer's regulatory process.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2115-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2115-2024 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.
