GMAX SYR 5ML/LL syringes (model TS2205L-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 5ML/LL syringes (model TS2205L-M) are recalled because they don't meet medical device clearance standards. Using them could lead to improper medical treatment if they're not designed for the intended purpose.
These syringes were not cleared for use as medical devices by the manufacturer. The device may not function correctly or safely when used for medical purposes, potentially leading to incorrect 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 TS2205L-M on the syringe. The product was sold with lot codes starting with SL21030101 through SL23120401.
Verify the model number on the syringe is TS2205L-M.
Reach out to Jiangsu Shenli Medical Production Co., Ltd. for further guidance on safe use or alternatives.
The recall indicates these syringes may not be safe for medical use due to incorrect device clearance. They should not be used for injections.
Look for the model number TS2205L-M and lot codes starting with SL21030101 through SL23120401.
The manufacturer does not provide a specific remedy, so contact them directly for guidance on safe use or disposal.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2109-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2109-2024 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.
