Medline recalls DRAPE PACK-CHOICE convenience kits (model DYNJ63118A) due to potential sterility risks from calibration errors during sterilization. Affected kits may not meet sterility standards.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline is recalling DRAPE PACK-CHOICE convenience kits (model DYNJ63118A) because calibration issues during sterilization could compromise sterility. This means the kits might not be safe for medical use.
Calibration errors in the sterilization equipment could lead to kits not meeting sterility standards. This means the kits might not be safe for medical use, potentially causing infections.
Healthcare workers using these kits for medical procedures are most at risk. The recall affects kits sold with specific model numbers and lot numbers.
Check for model number DYNJ63118A on the kit. Kits with lot number 25ABV005 or UDI-DI numbers 10195327644291 and 40195327644292 are affected.
Look for model number DYNJ63118A and lot number 25ABV005 on the kit.
The recall is due to potential calibration issues during sterilization that could affect sterility assurance levels.
Check for model number DYNJ63118A and lot number 25ABV005 on the kit.
The recall record does not specify a remedy, so contact Medline directly for guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2122-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2122-2026 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.
