FDAFDA · Food and drugs·Recall number Z-1729-2018
BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
Published May 16, 2018 · Recall initiated: October 19, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Datascope Corporation
- Distributor
- Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.
- Lot
- Lot 3000057378, 3000061216
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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