Datascope recalls BEQ-TOP 8504 1/4X1/4 Pack tubing kits with catalog number 701066949R02 due to potential air entry causing blood flow drops in ECMO circuits. Affected units sold with lot 3000060844.
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 certain BEQ-TOP 8504 1/4X1/4 Pack tubing kits that could allow air to enter the ECMO circuit, potentially reducing blood flow. This risk affects patients using extracorporeal membrane oxygenation (ECMO) systems.
The seal between the tubing and housing may separate, letting air into the ECMO circuit. This can increase resistance and cause blood flow to drop, which is dangerous for patients on life support.
Patients using ECMO systems with the recalled tubing kits are most at risk. Healthcare providers who have purchased or use these specific kits should check if their equipment is affected.
Check for the catalog number 701066949R02 on the tubing kit. The affected units were sold with lot number 3000060844.
Look for the catalog number 701066949R02 and lot number 3000060844 on the tubing kit packaging.
Yes, the seal separation could allow air to enter the ECMO circuit, potentially reducing blood flow and causing harm to patients on life support.
Check for the catalog number 701066949R02 and lot number 3000060844. If you have these, contact Datascope for guidance.
The affected units have catalog number 701066949R02 and were sold with lot number 3000060844.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1718-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1718-2018 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.
