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Terminated

Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) (Italy). The product is intended for use in cardiopulmonary bypass circuits as a device to replace the function of the lungs in order to control the arterial/venous temperature and as a venous blood reservoir

FDA Recall Z-2469-2008 · Posted 2008-09-30

Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeDTZ
Date Initiated2008-08-08
Date Terminated2008-09-30
Product Quantity35 units

Reason for Recall

Under certain conditions, venous reservoir on oxygenator may allow air into the system.

Firm Action

The firm sent out a notification letter, by certified letter, on Aug 8,2008. Instructions on how to prevent air from entering the system were provided. Sorin Group USA, Inc. can reached at 1-303-467-6306.

Root Cause

Labeling False and Misleading

Distribution Pattern

NC

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991737LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATORDideco S.P.A. · 2000-02-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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