Datascope recalls Adult ECC Pack BEQ-TOP 22300 (Catalog No. 701049504) due to potential air entry causing blood flow drops in ECMO circuits. Affected units include specific 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 its Adult ECC Pack BEQ-TOP 22300 to prevent air from entering the device, which could reduce blood flow in ECMO circuits. This risk affects patients using extracorporeal membrane oxygenation systems.
Seal separation in the device can allow air to enter the housing, increasing resistance in the venous line. This may cause a drop in blood flow through the ECMO circuit, potentially harming patients.
Patients using extracorporeal membrane oxygenation (ECMO) systems with this specific device are most at risk. Healthcare providers who use the product in clinical settings may also be affected.
Check for the product name 'Adult ECC Pack BEQ-TOP 22300' and catalog number 701049504. Affected units include specific lots: 3000057378 and 3000061216.
Inspect the device for signs of seal separation that could allow air entry.
The recall states that seal separation may cause air entry, but the device is safe if the seal remains intact.
The recall does not specify a remedy, so contact Datascope Corporation for guidance.
Affected lots are 3000057378 and 3000061216.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1708-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1708-2018 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.
