Agency classClass IIOur severity:Severe FDA (Devices)·Z-1726-2018·Announced 2018-05-16

Datascope Recalls BEQ-TOP 24500 Adult ECC Custom Tubing Kits

Datascope is recalling four BEQ-TOP 24500 Adult ECC Custom Tubing Kits because a seal defect may allow air to enter 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 recall is classified as FDA Class II and involves a structural defect in a 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 four units of the BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253. The recall involves specific lots identified as 3000055326 and 3000064943. 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 was initiated because the Better Bladder device included in some of these custom tubing kits may experience seal separation from the housing. This defect can allow air to enter the housing, which may cause the balloon to collapse. If the balloon collapses, it may increase resistance to flow in the venous line and cause a drop in blood flow within the ECMO circuit.

Healthcare providers and facilities that have received these specific kits should stop using them immediately and contact Datascope Corporation for instructions on how to return or dispose of the affected units.

The recalled product

Product: BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
Manufacturer: Datascope Corporation
Category: Medical Device — Cardiovascular / ECMO
Hazard: structural-defect
air-embolism
flow-restriction
Affected units: 4

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 3000055326
3000064943

Distribution

Distributed in 13 states:

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.

See all 28 products in this recall →

Same manufacturer · Datascope Corporation

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Same hazard · structural defect