GMAX SYR 5ML/LL syringes (model TS2205S-M) without needles are recalled due to incorrect medical use risks. Non-sterile syringes may not be safe for medical procedures.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 5ML/LL syringes (model TS22:05S-M) without needles are recalled because they may not be safe for medical use. These non-sterile syringes could cause incorrect medical procedures if used improperly.
The syringes may not meet medical device clearance standards, meaning they could be unsafe for medical procedures. This risk arises because the syringes' sizes and configurations differ from those approved for use.
People who own or use GMAX SYR 5ML/LL syringes (model TS2205S-M) without needles are affected. Medical users are at higher risk due to potential incorrect use.
Check for the model number TS2205S-M on the syringe. These non-sterile syringes without needles were sold with lot codes SL22070103, SL22030103, SL21120111, SL21090103, and SL21030103.
Look for the model number TS2205S-M on the syringe to confirm it is recalled.
The recall states these syringes may not be safe for medical use due to incorrect device clearance.
The recall does not specify a remedy, so contact the manufacturer for guidance.
Check for the model number TS2205S-M and lot codes SL22070103, SL22030103, SL21120111, SL21090103, or SL21030103.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2124-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2124-2024 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.
