MEDLINE recalls SYR 10ML L/S non-sterile syringes (model 83081) that may not meet device clearance standards. Affected units include specific lot codes from June 2023.
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/S non-sterile syringes (model 83081) because they may not meet the required device clearance standards. This could lead to improper use in medical settings if the syringes are used without proper validation.
The syringes may not meet the device clearance standards approved by the manufacturer. This means they could be used incorrectly in medical procedures, potentially leading to improper administration of medication or fluids.
Healthcare professionals and patients using the recalled syringes for medical procedures. Those most at risk are individuals who have received the specific lot codes listed in the recall.
Check for the model number 83081 on the syringe packaging. The affected units include specific lot codes starting with 63721 and 63722 from June 2023.
Look for lot codes such as 63721010001, 63721050002, or 63722010001 on the syringe packaging.
The recall indicates they may not meet device clearance standards, so they should not be used until the recall is resolved.
Check the lot code on the syringe packaging. If it matches the listed codes, contact MEDLINE for instructions.
Look for the model number 83081 and lot codes starting with 63721 or 63722 from June 2023.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2046-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2046-2024 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.
