Beq-top 38900 ECC Pack recall
BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
Why was Beq-top 38900 ECC Pack 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 3000060487
- Product
- BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
- Recalling firm
- Datascope Corporation
- Quantity
- 9
- 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)