Datascope recalls NICU ECC Pack BEQ-TOP 39202 custom tubing kits due to potential air entry into ECMO circuits, risking blood flow drops. Affected units have Catalog No. 701067313R01 and Lot 3000061508.
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 NICU ECC Pack BEQ-TOP 39202 custom tubing kits because a seal issue might let air enter the ECMO circuit, causing blood flow problems. This could lead to reduced blood flow in critical care settings.
The Better Bladder device in the tubing kit can develop seal separation, allowing air to enter the housing. This may collapse the balloon and increase resistance in the venous line, reducing blood flow through the ECMO circuit.
Healthcare providers using NICU ECMO circuits with the recalled tubing kits are most at risk. Patients on extracorporeal membrane oxygenation (ECMO) therapy are particularly vulnerable.
Check for the NICU ECC Pack BEQ-TOP 39202 custom tubing kit with Catalog Number 701067313R01 and Lot Number 3000061508. The product is sold in hospitals for neonatal intensive care units.
Look for the NICU ECC Pack BEQ-TOP 39202 custom tubing kit with Catalog Number 701067313R01 and Lot Number 3000061508.
The Better Bladder device in the tubing kit may develop seal separation, allowing air to enter the housing and collapse the balloon, which could reduce blood flow in ECMO circuits.
Seal separation might cause air entry, increasing resistance in the venous line and potentially dropping blood flow in ECMO circuits.
Check for the NICU ECC Pack BEQ-TOP 39202 custom tubing kit with Catalog Number 701067313R01 and Lot Number 3000061508.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1725-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1725-2018 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.
