Galt Medical recalls specific Centeze catheter models due to incorrect tip geometry causing potential blockage. Affected units include certain lot numbers and catalog codes from 2010-2023.
Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
Galt Medical is recalling specific Centeze catheter models because the catheter tip has a thicker wall and more obtuse angle than intended. This could lead to blockages during medical procedures, which may cause complications for patients needing the catheter.
The catheter tip has a thicker wall and more obtuse angle than designed, which could cause blockages during medical procedures. This might lead to complications for patients who need the catheter for treatments like draining fluid from the body.
Patients using the recalled catheter models for medical procedures are most at risk. Healthcare providers who use these specific models for treatments may also be affected.
Check for the catalog number DRC-002-06 or DRC-006-16 on the catheter packaging. Affected units include specific lot numbers with UDI codes starting with 20108509, 20139676, 20148911, 20160253, or 20189100.
Look for the catalog number DRC-002-06 or DRC-006-16 on the catheter packaging.
The catheter tip has a thicker wall and more obtuse angle than intended due to a manufacturing issue.
Centeze Centesis Catheter models with catalog numbers DRC-002-06 or DRC-006-16 and specific lot numbers listed in the recall notice.
Check the packaging for the catalog number DRC-002-06 or DRC-006-16 and look for the listed lot numbers with UDI codes.
We’ve drafted a message you can send Galt Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0568-2021 — Galt Medical Galt Medical Hello, I own a Galt Medical that is covered by recall Z-0568-2021 from Galt Medical. 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.
