MEDLINE recalls SYR 30ML/LS non-sterile syringes with model 83077 that may not meet device clearance standards. These syringes could be unsafe 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 non-sterile syringes with model number 83077 because they may not meet the required device clearance standards. Using these syringes could lead to unsafe medical procedures.
The syringes may not meet the required device clearance standards, meaning they could be unsafe for medical use. This is due to piston syringe sizes and configurations being outside the range of devices cleared by the manufacturer.
Medical professionals and patients who own or use these specific syringes are affected. The risk is low as the issue relates to device clearance rather than immediate safety hazards.
Check for the model number 83077 on the syringe packaging. These syringes are non-sterile and without needles for single use. The lot codes listed in the recall include specific numbers like 63721010001.
Look for the model number 83077 and lot codes such as 63721010001 on the syringe packaging.
The recall states these syringes may not meet device clearance standards, so they are not recommended for use.
The recall does not specify a remedy, so you should check with the manufacturer or healthcare provider for guidance.
Look for the model number 83077 and lot codes listed in the recall, such as 63721010001.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2042-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2042-2024 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.
