Vascular Solutions recalls Drainer centesis catheters (REF 8810, 8811, 8812) due to potential unsafe bacterial endotoxin levels in specific production lots. Affected lot numbers are listed for identification.
The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.
Vascular Solutions is recalling three types of Drainer centesis catheters because certain production lots may contain unsafe levels of bacterial endotoxins. This could pose a risk of infection or other complications if the catheters are used.
The catheters may contain unsafe levels of bacterial endotoxins, which can cause infections or other complications if the catheters are used in medical procedures. Endotoxins are substances released by bacteria that can trigger adverse reactions in the body.
Healthcare professionals and patients who use the recalled Drainer centesis catheters for fluid drainage procedures are affected. Those using the specific lot numbers listed are at the highest risk.
Check the product label for the model number (REF 8810, 8811, or 8812) and the lot number (18037128, 18057123, 18026062, 18026063, or 18050076) to identify if your catheter is affected.
Look for the model number (REF 8810, 8811, or 8812) and lot number on the catheter packaging or label.
Drainer centesis catheters with model numbers REF 8810 (5F x 9cm), REF 8811 (6F x 9cm), and REF 8812 (5F x 15cm).
Lot numbers 18037128, 18057123 for REF 8810; 18026062, 18026063 for REF 8811; and 18050076 for REF 8812.
The recall does not specify a stop-use instruction; the hazard is potential bacterial endotoxins, which is a low-risk concern for most users.
We’ve drafted a message you can send Vascular Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-2249-2018 — Vascular Solutions Vascular Solutions Hello, I own a Vascular Solutions that is covered by recall Z-2249-2018 from Vascular Solutions. 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.
