MEDLINE SYR 3ML L/L non-sterile syringes (model 83084) recalled because piston sizes don't match cleared devices. Affected lots: 63720120007-63723120002. No remedy stated in recall notice.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
MEDLINE's SYR 3ML L/L non-sterile syringes (model 83084) are being recalled because their piston sizes don't match the medical devices cleared by the manufacturer. This could lead to improper use if the syringes are used with devices they weren't designed for, potentially causing errors in medical procedures.
The syringes' piston sizes and configurations fall outside the range of devices cleared by the manufacturer's 510(k) approval. This means they might not function correctly with medical devices they were intended for, potentially causing errors in medication delivery or dosing.
Users of MEDLINE SYR 3ML L/L non-sterile syringes (model 83084) with lot numbers listed in the recall notice are affected. Healthcare professionals and patients using these syringes for single-use medical procedures are most at risk.
Check for the model number 83084 on the syringe packaging. Look for lot codes starting with 63720120007 through 63723120002. These syringes are non-sterile and do not include needles.
Identify the lot code on the syringe packaging to see if it matches the listed numbers (63720120007-63723120002).
The recall states the syringes' piston sizes don't match cleared devices, so they may not function correctly with medical devices they were intended for. They are not recommended for use.
The recall notice does not specify a remedy, so you should check the lot code and contact MEDLINE for further instructions.
No, these are non-sterile syringes without needles for single use.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2049-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2049-2024 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.
