MEDLINE recalls SYR 20ML L/L WHITE SALINE syringes (model 91858) due to being cleared for use outside approved device ranges. These non-sterile syringes without needles may pose risks if used with devices not cleared for their size.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
MEDLINE is recalling SYR 20ML L/L WHITE SALINE syringes (model 91858) because they were not approved for the specific device sizes and configurations they were designed for. Using these syringes with devices that require different sizes could lead to improper function or injury.
The syringes were designed for sizes and configurations that do not match the devices cleared by the manufacturer. This mismatch could cause improper function, such as incorrect dosing or failure to deliver medication, potentially leading to medical errors.
Users of MEDLINE SYR 20ML L/L WHITE SALINE syringes (model 91858) with lot codes listed in the recall notice are affected. Healthcare professionals and patients using these syringes for medical purposes are at risk if the device is not properly cleared for their size.
Check for the model number 91858 on the syringe packaging. Look for lot codes: 63721010001, 63721070001, 63721090001, 63721100001, 63721120001, 63722020002, 63722050001, 63722100003, 63723020001, 63723030001, 63723050001, 63723060001, 63723070001, 63723120002.
Verify the model number on the syringe packaging to confirm it is 91858.
Check for lot codes listed in the recall notice: 63721010001, 63721070001, 63721090001, 63721100001, 63721120001, 63722020002, 63722050001, 63722100003, 63723020001, 63723030001, 63723050001, 63723060001, 63723070001, 63723120002.
The recall states these syringes were not cleared for the specific device sizes they were designed for, so they may not be safe for intended use. Do not use them without confirming they are approved for your device.
The recall does not specify a remedy, so contact MEDLINE directly for guidance on safe disposal or replacement.
Check for the model number 91858 and lot codes listed in the recall notice.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2086-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2086-2024 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.
