MEDLINE recalls non-sterile 30ml syringes (model 83078) due to incorrect device clearance. Affected units include specific lot codes. Consumers should check their syringes for the listed lot numbers.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
MEDLINE is recalling non-sterile 30ml syringes (model 83078) because they don't meet the required device clearance standards. This could lead to improper use if the syringes are used for medical purposes without proper validation.
The syringes have sizes and configurations that don't match the devices cleared by the manufacturer's 510(k) approval. This means they might not function correctly or safely when used for medical procedures.
Users of non-sterile 30ml syringes with the listed lot codes are affected. Healthcare professionals and individuals using these syringes for medical purposes are at the highest risk.
Check for the model number 83078 on the syringe. Affected units include specific lot codes: 63720120007, 63721010002, 63721050002, and other listed codes.
Look for the lot code on the syringe to determine if it's affected. Affected lot codes include 63720120007, 63721010002, 63721050002, and others listed in the recall.
The recall states these syringes have sizes and configurations outside the cleared device range, so they may not be safe for medical use. Do not use them.
Check the lot code on the syringe. If it matches the listed codes, stop using it and contact MEDLINE for further instructions.
Look for the model number 83078 and check the lot code against the list of affected codes provided in the recall notice.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2043-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2043-2024 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.
