MEDLINE recalls SYR 5ML L/L RED non-sterile syringes (model 91825) due to device not being cleared for use. This may pose risks if used without proper approval.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
MEDLINE is recalling SYR 5ML L/L RED non-sterile syringes (model 91825) because they were not cleared for use by the manufacturer's regulatory body. Using these syringes could lead to improper medical procedures if they don't meet safety standards.
The syringes were not cleared by the manufacturer's regulatory body for the intended use. This means they might not function correctly or safely during medical procedures, potentially causing harm.
Patients and healthcare providers who own or use these syringes may be affected. Those using the syringes for medical procedures are at higher risk due to potential device incompatibility.
Check for the model number 91825 on the syringe packaging. The lot codes listed (e.g., 63721010001) indicate specific batches to recall.
Look for the model number 91825 on the syringe packaging or label.
The syringes were not cleared by the manufacturer's regulatory body for the intended medical use, which could lead to improper function.
Check the model number and lot codes to see if your syringes are affected. If they are, contact MEDLINE for instructions.
The recall indicates they were not cleared for use, so they may not be safe for medical procedures.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2057-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2057-2024 from MEDLINE. 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.
