Medline recalls convenience kits containing unapproved 10mL polycarbonate colored syringes that were not initially reported in FDA clearance. Affected kits may have design changes outside FDA 510(k) clearance.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Medline is recalling convenience kits that include certain 10mL polycarbonate colored syringes. These syringes were made with unapproved design changes not cleared by the FDA, meaning they might not be safe for medical use.
The syringes were modified without proper FDA approval, which could lead to safety issues if used in medical procedures. Products not initially reported in FDA clearance might not meet safety standards.
Healthcare professionals and patients using the recalled convenience kits with specific syringe models are affected. Those who have the kits with the listed lot numbers are most at risk.
Check for the product name 'PICC LINEPACK (PCLUI)642-LF' with the model DYNJ47717A and lot numbers listed in the recall notice. The kits were sold with specific batch numbers from 2021 to 2022.
Identify the lot numbers on the syringe kits to confirm if they match the affected lots listed in the recall.
The syringes have unapproved design changes not cleared by the FDA, which could pose safety risks during medical use.
Look for the model DYNJ47717A with lot numbers 21CMD153 through 22LMC336 on the convenience kits.
The recall does not specify a remedy, so check with Medline directly for guidance on next steps.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2595-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2595-2026 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.
