Medline recalls sterile 3mL syringes with 21GA needles due to packaging seal voids causing sterility loss. Affected units: lot 18JBH655 (01) 1088438982153. No remedy specified in official notice.
Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
Medline is recalling sterile 3mL syringes with 21GA needles because packaging seals can develop voids, risking loss of sterility. This could lead to contamination if the syringes are used for medical procedures. The recall affects a specific production lot.
The packaging seal may develop voids, allowing contaminants to enter the syringe contents. This compromises sterility, which is critical for medical procedures where contamination could cause infections.
Healthcare professionals using these syringes for medical procedures are most at risk. Patients receiving injections with affected syringes could face contamination.
Check for the lot number 18JBH655 (01) 1088438982153 on the packaging. The product is a sterile 3mL syringe with a 21-gauge 1-inch needle, sold in packs of 80.
Look for the lot number 18JBH655 (01) 1088438982153 on the packaging to confirm if your syringes are affected.
The recall is due to voids in the packaging seal that can cause loss of sterility in the syringes.
Check for the lot number 18JBH655 (01) 1088438982153 on the packaging. The product is a sterile 3mL syringe with a 21-gauge 1-inch needle.
The official notice does not specify a remedy for this recall.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1546-2020 — Medline Medline Hello, I own a Medline that is covered by recall Z-1546-2020 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.
