MEDLINE recalls SYR 10ML L/L YELLOW HEP/SALINE syringes (model 91855) due to not being cleared for use. These non-sterile syringes without needles 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 10ML L/L YELLOW HEP/SALINE syringes (model 91855) because they were not approved for use. This could lead to improper medical treatment if used without proper clearance.
The syringes were not cleared by the manufacturer's regulatory body for their intended use. This means they might not function safely or effectively in medical procedures, potentially causing harm.
Users of these syringes for medical purposes may be affected. Healthcare professionals and patients using non-sterile syringes without needles are at risk.
Check for the model number 91855 on the syringe packaging. These non-sterile syringes without needles are for single use and were sold with lot code 63723100003.
Look for the model number 91855 and lot code 63723100003 on the syringe packaging.
The recall states the syringes were not cleared for use, so they may not be safe for medical purposes.
The recall does not specify a remedy, so check with the manufacturer for guidance.
The recall indicates the syringes were not approved for use, which could lead to improper medical treatment.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2083-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2083-2024 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.
