MEDLINE recalls SYR 3ML L/L RED non-sterile syringes (model 91820) due to device not being cleared for use. This may pose risks if used with medical devices requiring specific configurations.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
MEDLINE is recalling SYR 3ML L: L RED non-sterile syringes (model 91820) because the syringes' sizes and configurations don't match medical devices they were cleared for. This could lead to improper use if the syringes are used with devices that require specific configurations.
The syringes' sizes and configurations are outside the range of devices cleared by the manufacturer. This means they might not work correctly with medical devices that require specific syringe sizes or configurations, potentially causing improper use.
Users of non-sterile syringes with model number 91820 are likely affected. Healthcare workers and patients using these syringes for medical procedures may be at risk if the syringes are used with devices requiring specific configurations.
Check for the model number 91820 on the syringe packaging. These are non-sterile syringes without needles for single use, sold by MEDLINE.
Look for the model number 91820 on the syringe packaging to confirm if it is recalled.
The recall states the syringes' sizes and configurations are not cleared for use with medical devices, so they may not be safe for intended medical procedures.
The recall does not specify a remedy, so you should check if they are the model 91820 and contact MEDLINE for further guidance.
The recall does not address non-medical use, but the syringes are non-sterile and intended for single use in medical procedures.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2054-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2054-2024 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.
