MEDIGRATIVE 100cc/ml disposable luer lock syringes (model 10025) may not fit medical devices due to size issues. Affected lots: EJ117-5 to EJ117-11. Stop using if unsure.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
MEDIGRATIVE 100cc/ml disposable luer lock syringes (model 10025) are being recalled because their size and configuration don't match medical devices cleared by the manufacturer. This could lead to improper use in medical settings.
The syringes' size and configuration are outside the range of devices approved for medical use. This could cause improper fitting or function when used with medical devices, potentially leading to incorrect dosing or device damage.
Healthcare professionals and patients using these syringes for medical injections may be affected. Those using the syringes for non-medical purposes are less likely to be impacted.
Check for the model number 10025 on the syringe. Look for lot codes EJ117-5 through EJ117-11 on the packaging or label.
Verify the model number is 10025 and the lot code is between EJ117-5 and EJ117-11.
The syringes' size and configuration don't match medical devices cleared by the manufacturer, which could lead to improper use.
Check the model number and lot code. If it matches the recalled model and lot codes, stop using it and contact the manufacturer for guidance.
The recall is for potential improper use with medical devices, but there is no immediate risk of injury or harm if used correctly.
We’ve drafted a message you can send MEDIGRATIVE to request your refund or repair — edit it as you like.
Subject: Recall Z-2100-2024 — MEDIGRATIVE MEDIGRATIVE Hello, I own a MEDIGRATIVE that is covered by recall Z-2100-2024 from MEDIGRATIVE. 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.
