Datascope recalls BEQ-TOP 22301 Custom Tubing Kit (Catalog 701049513) due to potential air entry causing ECMO blood flow drops. Affected units sold with Lot 3000060036.
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 custom tubing kits for ECMO use because air could enter the device and reduce blood flow in life-support systems. This could cause serious complications for patients on ECMO treatment.
The tubing kit's seal may separate, letting air into the device housing. This air can collapse the balloon inside, increasing resistance in the venous line and reducing blood flow through the ECMO circuit.
Patients using ECMO life support systems with the recalled tubing kits are at risk. Healthcare providers who use these kits for medical procedures may need to take action.
Check for the product name 'BEQ-TOP 22301 Custom Tubing Kit' with Catalog Number 701049513. Affected units were sold with Lot 3000060036.
Verify the catalog number and lot number to confirm if your unit is affected.
The recall indicates a potential risk, so it is not safe to use without checking if it's affected.
The recall record does not specify a remedy, so contact Datascope Corporation for guidance.
Look for the product name 'BEQ-TOP 22301 Custom Tubing Kit' with Catalog Number 701049513 and Lot 3000060036.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1728-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1728-2018 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.
