TeDan Surgical Innovations recalls Fukushima Malleable Tapered Suction tubes (Lot 0619) due to incorrect raw materials used in production. These reusable surgical instruments are used in hospitals to remove debris and blood during procedures.
There was incorrect raw material used in the production of the identified lot.
TeDan Surgical Innovations is recalling Fukushima Malleable Tapered Suction tubes (Lot 0619) because they were made with incorrect raw materials. This could affect surgical safety if the tubes are used in procedures.
The tubes were produced using incorrect raw materials, which could lead to improper function during surgery. This might cause issues like ineffective debris removal or potential harm to patients if the tubes fail during critical procedures.
Surgical teams and hospitals that use these specific suction tubes (Lot 0619) are affected. Patients undergoing surgery with these tubes may be at risk.
Check for the product name 'Fukushima Malleable Tapered Suction, 3 FR, 145 MM' and the lot number '0619' on the tube packaging or label.
Look for the lot number '0619' on the tube packaging or label to confirm if it is part of the recall.
The recall is due to incorrect raw materials used in the production of the identified lot (Lot 0619).
The official recall notice does not specify a remedy or action steps for affected users.
The recall indicates potential safety issues, but the official notice does not provide details on how the incorrect materials might affect safety.
We’ve drafted a message you can send TeDan Surgical Innovations to request your refund or repair — edit it as you like.
Subject: Recall Z-1845-2020 — TeDan Surgical Innovations TeDan Surgical Innovations Hello, I own a TeDan Surgical Innovations that is covered by recall Z-1845-2020 from TeDan Surgical Innovations. 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.
