Datascope recalls BO-TOP 20705 Small Patient 1/4 tubing kits due to potential air entry causing blood flow drops in ECMO circuits. Affected units have specific catalog and lot numbers.
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Datascope is recalling some small patient 1/4 tubing kits because air could enter the device and reduce blood flow in ECMO systems. This could cause serious complications for patients using extracorporeal membrane oxygenation.
The tubing kit's seal may separate, allowing air to enter the device housing. This can collapse the balloon inside, increasing resistance in the venous line and reducing blood flow through the ECMO circuit.
Patients using ECMO systems with this specific tubing kit are most at risk. Healthcare providers who use the recalled product for medical treatments may also be affected.
Check for the catalog number 701053486 and lot number 3000061302 on the tubing kit. The product is sold as part of custom tubing kits for small patient use.
Look for catalog number 701053486 and lot number 3000061302 on the tubing kit.
The catalog number is 701053486.
The recall record does not mention any remedy or fix.
Air entering the device could reduce blood flow in ECMO circuits, potentially causing serious complications.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1713-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1713-2018 from Datascope. 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.
