GMAX SYR 12ML/LS syringes (model TS221:2S-M) without needles are recalled due to incorrect medical device clearance. These non-sterile syringes may not be safe for medical use as they don't meet regulatory standards.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 12ML/LS syringes (model TS2212S-M) without needles are being recalled because they don't meet medical device clearance standards. Using these syringes could lead to incorrect medical treatments if they are not properly sized or configured for the intended use.
The syringes have piston sizes and configurations that do not match the medical devices cleared by the manufacturer. This means they might not function correctly during medical procedures, potentially leading to incorrect dosing or treatment.
Users of these non-sterile syringes for medical purposes are affected. Healthcare professionals and patients using these syringes for injections may be at risk if they are not properly sized for medical use.
Check for the model number TS2212S-M on the syringe. These non-sterile syringes without needles were sold with lot codes SL22120209, SL23080314, or SL23100201.
Look for the model number TS2212S-M on the syringe to confirm it is part of the recall.
No, these syringes have piston sizes and configurations that do not meet the medical device clearance standards, so they are not safe for medical use.
The recall does not specify a remedy, so you should check with the manufacturer or healthcare provider for guidance.
Look for the model number TS2212S-M and lot codes SL22120209, SL23080314, or SL23100201 on the syringe.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2118-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2118-2024 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.
