Datascope recalls NICU ECC Pack custom tubing kits due to seal defect
Datascope is recalling specific NICU ECC Pack custom tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow in ECMO circuits.
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 recall is classified as FDA Class II and involves a structural defect in a critical life-support device (ECMO) that can cause a drop in blood flow, meeting the criteria for a Severe rating.
Plain-English summary
Datascope Corporation is recalling three units of the NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01. The affected units are identified by Lot 3000061508. These 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 recall is being conducted because the Better Bladder device included in these custom tubing kits may experience seal separation from the housing. This defect can allow air to enter the housing and cause the balloon to collapse. Such a failure may increase resistance to flow in the venous line and cause a drop in blood flow within the ECMO circuit.
Healthcare facilities and accounts that received these specific units should stop using the affected custom tubing kits and contact Datascope Corporation for further instructions on the recall.
The recalled product
- Product
- NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
- 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 (1)
- Lot 3000061508
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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