Agency classClass IIOur severity:High FDA (Devices)·Z-2178-2018·Announced 2018-06-20

Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

Datascope Corporation is recalling 10 units of Maquet Cardiopulmonary Bypass Custom Tubing kits because the over-pressure safety valve may fail to allow 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device with a potential functional failure (valve not allowing flow) where no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Datascope Corporation is recalling 10 units of the Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035. The recall was initiated because there is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.

The affected products were distributed to the states of Iowa and Florida. The device is a sterile, non-pyrogenic, single-use system used for extracorporeal support during cardiopulmonary bypass procedures.

Healthcare facilities should stop using the affected units and contact Datascope Corporation for further instructions.

The recalled product

Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product…
Manufacturer: Datascope Corporation
Category: Medical Device — Cardiopulmonary Bypass
Hazard: functional-failure
Affected units: 10

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)

UDI 0607567204133

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Datascope Corporation

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Same hazard · functional failure