Wolf Medical recalls 12mL Luer Lock syringes due to potential mismatch with cleared medical devices. Affected units include specific lot codes from 2019-2023. Contact for return instructions.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Wolf Medical is recalling 12mL Luer Lock syringes that may not be compatible with medical devices cleared by the manufacturer. This could lead to incorrect use if the syringe is used with devices it wasn't designed for, potentially causing harm.
The syringes have sizes and configurations that don't match the medical devices cleared by the manufacturer. This mismatch could lead to incorrect use, potentially causing harm if the syringe is used with devices it wasn't designed for.
Healthcare professionals and patients using Wolf Medical 12mL Luer Lock syringes with specific lot codes from 2019 to 2023 are affected. Those using these syringes with medical devices cleared by the manufacturer are at higher risk.
Check for lot codes: 20190517, 20191014, 20200204, 20200301, 20210301, 20210901, 20211112, 20220414, 20220614, 20221015, 20231006. The product is a non-sterile syringe without needles for single use.
Identify the lot code on the syringe packaging to see if it matches the affected codes listed.
The syringes have sizes and configurations that don't match the medical devices cleared by the manufacturer, which could lead to incorrect use.
Lot codes: 20190517, 20191014, 20200204, 20200301, 20210301, 20210901, 20211112, 20220414, 20220614, 20221015, 20231006.
Check the lot code on the syringe packaging; if it matches the listed codes, it is affected.
We’ve drafted a message you can send Wolf Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2104-2024 — Wolf Medical Wolf Medical Hello, I own a Wolf Medical that is covered by recall Z-2104-2024 from Wolf Medical. 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.
