Datascope recalls BEQ-TOP 50903 Custom ECC Pack-Pedriatric tubing kits due to potential air entry causing blood flow drops in ECMO circuits. Affected units have specific catalog numbers and lots.
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 pediatric ECMO tubing kits because a seal issue might let air enter the device, reducing blood flow in life-support systems. This could lead to serious complications for patients using extracorporeal membrane oxygenation.
The tubing kit's seal may separate from the housing, allowing air to enter the device. This can increase resistance in the venous line and reduce blood flow through the ECMO circuit, potentially causing serious complications for patients.
Parents and caregivers of infants using ECMO systems with the recalled tubing kits are most at risk. The specific model and lot numbers are required to confirm affected units.
Check for the catalog number 709000078 on the tubing kit packaging. Affected units were sold with lot number 3000063290.
Verify the catalog number 709000078 and lot number 3000063290 on the tubing kit packaging.
Yes, the seal separation could allow air entry, increasing resistance and reducing blood flow in ECMO circuits, which may cause serious complications.
Check for catalog number 709000078 and lot number 3000063290 on the tubing kit packaging.
The recall record does not specify a remedy, so contact Datascope Corporation for guidance.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1733-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1733-2018 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.
