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Recall Observatory FDA recall evidence

Device product

BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01

Z-1717-2018

October 19, 2017

Class II

Product summary

Firm
Datascope Corporation
Event
Event 79873
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-1717-2018

Official wording

Reason: 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.

Code information: Lot 3000059724

Distribution pattern: Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.