MEDLINE recalls SYR 1ML TB non-sterile syringes (model 83089) due to piston sizes not matching cleared devices. Affected lots may cause incorrect dosing if used with 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 1ML TB non-sterile syringes (model 83089) because their piston sizes don't match the devices cleared for use. This could lead to incorrect dosing if used with medical devices that require specific configurations.
The syringes' piston sizes and configurations are outside the range of devices cleared by the manufacturer. This mismatch could cause incorrect dosing when used with medical devices that require specific piston configurations.
Healthcare professionals and patients using these syringes for medical injections may be affected. Those using the syringes with devices that require precise piston configurations are at higher risk.
Check for the model number 83089 on the syringe packaging. Affected lots include specific sequences like LOT: 63720120007 through 63723120002.
Look for lot codes in the sequence 63720120007 through 63723120002 on the syringe packaging.
The recall indicates the syringes may not be safe for use with devices requiring specific piston configurations. They are non-sterile and intended for single use.
Check the lot code on the syringe packaging. If it matches the affected lots listed, stop using it and contact MEDLINE for further instructions.
The syringes' piston sizes and configurations are outside the range of devices cleared by the manufacturer, which could lead to incorrect dosing when used with medical devices requiring specific configurations.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2053-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2053-2024 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.