Imactis recalls navigation kits with potential microbial contamination in sensor covers, risking pyrogenic responses. Affected kits include specific model numbers and expiration dates.
The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. A source of microbial contamination has been identified in a raw product used to manufacture the tip of the cover.This could result in direct exposure of the intra-cardiovascular, intra-lymphatic or neurological system to a level of endotoxin sufficient to produce a pyrogenic response.
Imactis is recalling navigation kits that may contain microbial contamination in the sensor cover. This could lead to serious health issues if the contaminated cover is used during medical procedures involving the heart, lymphatic system, or nerves.
The sensor cover in the navigation kit may contain microbial contamination from a raw product used to make its tip. This contamination could expose the heart, lymphatic system, or nerves to endotoxins, causing a fever-like reaction or other serious health issues.
Medical professionals using the navigation kits for procedures involving the heart, lymphatic system, or nerves are most at risk. Patients undergoing such procedures with the recalled kits could be exposed to harmful contaminants.
Check for the model numbers REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, and Sensor Cover Ref. PC3688 CE 0482. The kits were sold with expiration dates Lot # 18120001 (expiring April 2020) and Lot # 19040001 (expiring January 2021).
Identify the model numbers and expiration dates listed in the product description to confirm if your kit is affected.
The recall is due to potential microbial contamination in the sensor cover, which could lead to serious health risks if used during medical procedures.
Contaminated kits could expose the heart, lymphatic system, or nerves to endotoxins, causing a pyrogenic response like fever or other serious reactions.
Check for the model numbers REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, and Sensor Cover Ref. PC3688 CE 0482, and expiration dates Lot # 18120001 (expiring April 2020) or Lot # 19040001 (expiring January 2021).
We’ve drafted a message you can send Imactis to request your refund or repair — edit it as you like.
Subject: Recall Z-0838-2020 — Imactis Imactis Hello, I own a Imactis that is covered by recall Z-0838-2020 from Imactis. 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.
