FDAClass IIMay 16, 2018

Beq-top 22702 ECC W/hmod 30000 recall

BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179

Why was Beq-top 22702 ECC W/hmod 30000 recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 3000058051

Product
BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
Recalling firm
Datascope Corporation
Quantity
1
Distribution
Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.
Recall date
May 16, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls