MEDLINE recalls non-sterile 60ml syringes (model 83080) due to incorrect device clearance. These syringes may not meet safety standards for intended use, requiring immediate action from affected users.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
MEDLINE is recalling non-sterile 60ml syringes (model 83080) because they were cleared for use in devices that don't match their actual size and configuration. This could lead to improper medical use if the syringes aren't compatible with the intended medical devices.
The syringes were cleared for use in medical devices but their actual size and configuration fall outside the approved range. This mismatch could cause improper function during medical procedures, potentially leading to incorrect dosing or device failure.
Users of MEDLINE SYR 60ML L/L syringes with model number 83080 are affected. Healthcare professionals and patients using these syringes for medical procedures are most at risk due to potential incompatibility with medical devices.
Check for the model number 83080 on the syringe packaging or label. These syringes are non-sterile and come without needles for single use. They were sold with specific lot codes listed in the recall notice.
Look for the model number 83080 on the syringe packaging or label to confirm if it is affected.
The recall indicates these syringes may not meet safety standards for intended use due to incorrect device clearance. Affected users should not use them until a replacement is obtained.
If you have the affected model (83080), stop using them immediately and contact MEDLINE for guidance on alternatives.
Check the model number on the syringe packaging or label. The affected model is 83080 with specific lot codes listed in the recall notice.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2045-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2045-2024 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.
