Datascope Recalls Adult ECC Pack Due to Seal Separation Risk
Datascope Corporation is recalling three units of the Adult ECC Pack BEQ-TOP 22300 because seal separation may allow air into the housing, potentially collapsing the balloon and reducing blood flow.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which typically corresponds to a severity score of 3 or 4. However, the defect involves a potential failure in an ECMO circuit (blood flow reduction), which constitutes a significant risk of injury or harm, warranting a score of 4.
Plain-English summary
The U.S. Food and Drug Administration has announced a recall of the Better Bladder device, which is included in certain custom tubing kits manufactured by Datascope Corporation. The specific product affected is the Adult ECC Pack BEQ-TOP 22300, identified by Catalog No. 701049504. Only three units are being recalled, associated with lot numbers 3000057378 and 3000061216.
The recall is necessary because the seal between the bladder and the housing may separate. This defect can allow air to enter the housing, which may cause the balloon to collapse. A collapsed balloon can increase resistance to flow in the venous line, potentially causing a drop in ECMO circuit blood flow.
These units 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 recall is classified as FDA Class II.
The recalled product
- Product
- Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
- Manufacturer
- Datascope Corporation
- Affected units
- 3
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 (2)
- Lot 3000057378
- 3000061216
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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