Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling 11 custom tubing kits containing the Better Bladder device due to a seal defect that may cause balloon collapse and reduced blood flow.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that may cause a drop in ECMO circuit blood flow, which constitutes a significant injury risk.
Plain-English summary
Datascope Corporation is recalling 11 units of the BO-TOP 13901 RAPID RESPONSE Custom Tubing Kit, Catalog No. 701054874. The recall involves the Better Bladder device provided as part of these kits.
The recall was initiated because seal separation from the housing may allow air to enter the housing and collapse the balloon. This defect may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
The affected products were distributed to accounts in Alabama, Arkansas, California, the District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas, and Washington. The specific lot number is 3000067221. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
- Manufacturer
- Datascope Corporation
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 3000067221
Distribution
Part of a larger recall action
This product is one of 28 recalled by Datascope Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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