MEDLINE recalls SYR 10ML/L BLUE CONTRAST syringes (model 91848) due to incorrect device clearance. These non-sterile syringes without needles may not be safe for medical use.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
MEDLINE is recalling SYR 10ML/L BLUE CONTRAST syringes (model 91848) because they were cleared for use without matching the intended device specifications. This could lead to unsafe medical procedures if used improperly.
The syringes were cleared for use without matching the intended device specifications. This could mean they don't work safely with medical equipment, potentially causing incorrect dosing or procedure failures.
Healthcare professionals and patients using these syringes for medical procedures may be affected. Those with the specific model number 91848 are most at risk.
Check for the model number 91848 on the syringe packaging. These are non-sterile syringes without needles for single use, sold by MEDLINE.
Look for the model number 91848 on the syringe packaging to confirm if it's recalled.
The syringes were cleared for use without matching the intended device specifications, which could lead to unsafe medical procedures.
The recall record does not specify a remedy, so check with MEDLINE for further instructions.
The recall indicates potential safety issues, so they should not be used until confirmed safe by the manufacturer.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2127-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2127-2024 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.