Ecolab recalls disposable accessory kits with certain lot numbers due to potential pouch seal wrinkles that could breach sterility during surgery. Affected kits are for use with Da Vinci Si robotic systems.
The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.
Ecolab is recalling disposable accessory kits for robotic surgery that may have pouch seals with wrinkles. These wrinkles could create channels that breach sterility, risking infection during surgery.
The pouches may develop wrinkles along the seal, creating a channel that allows contamination. This breach could compromise sterility during surgery, potentially leading to infections if the kit is used without proper sterility.
Surgical teams using the Da Vinci Si robotic system with specific lot numbers of Ecolab's disposable accessory kits. The risk is primarily for procedures requiring sterile environments.
Check for lot numbers D173147, D173177, D173517, and other specific numbers listed in the recall notice. These kits are individually sealed in poly-Tyvek pouches for use with the Da Vinci Si robotic system.
Identify the lot numbers from the list provided in the recall notice to determine if your kit is affected.
The pouches of certain lots may have wrinkles that create channels in the seal, potentially breaching sterility during surgery.
The recall notice does not specify a remedy, so check the lot numbers and contact Ecolab if you need further assistance.
The potential breach in sterility could lead to infection risks during surgery, but the recall is for specific lot numbers and not all kits.
We’ve drafted a message you can send Ecolab to request your refund or repair — edit it as you like.
Subject: Recall Z-0234-2019 — Ecolab Ecolab Hello, I own a Ecolab that is covered by recall Z-0234-2019 from Ecolab. 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.
