MEDLINE recalls 10ml L/L red syringes (model 91856) due to device not cleared for use. These non-sterile syringes 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 10ml L/L red syringes (model 91856) because they were not approved for use as intended. Using these syringes could lead to improper medical procedures if they don't meet safety standards.
The syringes were not cleared by the manufacturer for the intended use. This means they might not function correctly or safely during medical procedures, potentially causing harm if used improperly.
Healthcare professionals and patients who own or use these non-sterile syringes for medical procedures are affected. Those using the syringes without proper medical clearance are at higher risk.
Check for the model number 91856 on the syringe packaging. These non-sterile syringes without needles are sold with lot codes 63721060001, 63722060001, or 63723030001.
Verify the model number on the syringe packaging to confirm it is 91856.
Reach out to MEDLINE directly for further assistance with the recall.
The recall indicates these syringes were not approved for use, so they may not be safe for medical procedures.
Check the model number and contact MEDLINE for guidance on next steps.
Look for model number 91856 with lot codes 63721060001, 63722060001, or 63723030001.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2084-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2084-2024 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.