MEDLINE recalls SYR 20ML/L WHITE CONTRAST syringes (model 91860) due to being cleared for devices outside the intended use. These non-sterile syringes without needles may pose risks if used incorrectly.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
MEDLINE is recalling SYR 20ML/L WHITE CONTRAST syringes (model 91860) because they were cleared for devices outside the intended use. Using these syringes could lead to incorrect medical procedures if not properly matched to the device they're meant for.
The syringes were cleared for devices outside the intended use range, meaning they might not function correctly with medical equipment. This mismatch could lead to incorrect dosing or procedure failures if used improperly.
Medical professionals and patients who own or use these non-sterile syringes without needles for single use. Those using them for medical procedures are most at risk if the syringes are mismatched with the intended device.
Check for the model number 91860 on the syringe packaging. These non-sterile syringes without needles are for single use and were sold with lot code 63722080002.
Look for the model number 91860 and lot code 63722080002 on the syringe packaging.
The recall states the syringes were cleared for devices outside the intended use range, so they may not be safe for proper medical procedures. Consult a healthcare provider for guidance.
The recall does not specify a remedy, so check with the manufacturer or healthcare provider for advice on safe handling.
Look for the model number 91860 and lot code 63722080002 on the syringe packaging.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2125-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2125-2024 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.
