—#73229

Product

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 product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K991737
Affected lot / code info: Lot No: 0501210038, and 0710290112.

Why it was recalled

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

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004

Distribution

Distribution pattern: NC

Timeline

Recall initiated: 2008-08-08
Posted by FDA: 2008-09-30
Terminated: 2008-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73229. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.