Medline recalls certain Open Heart kits with incorrect labeling that could lead to confusion in medical use. Affected kits have specific lot numbers and model discrepancies.
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Medline is recalling specific Open Heart kits that were incorrectly labeled during manufacturing. This could cause confusion in medical procedures if the wrong model is used, potentially leading to incorrect patient care.
During manufacturing, certain kits were labeled with the wrong model number (30000 instead of 30001). This labeling error could lead to confusion in medical procedures if the incorrect model is used, potentially causing incorrect patient care.
Healthcare professionals using Medline Open Heart kits with the specific lot number 23LBR364 are affected. Those handling these kits during medical procedures are at the highest risk.
Check for the lot number 23LBR364 on the kit packaging. The product is identified by the reference number DYNJ904261B and has specific UDI/DI codes.
Verify the lot number on the kit packaging; affected kits have lot number 23LBR364.
The kits were incorrectly labeled during manufacturing, with model 30001 labeled as model 30000. This could cause confusion in medical procedures.
Check the lot number on the packaging; if it is 23LBR364, contact Medline for further instructions.
The labeling error could lead to confusion in medical procedures, but there is no immediate risk of injury or harm if used correctly.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0122-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-0122-2025 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.