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Terminated

Cobe Optimin Hollow Fiber Sealed System, Sterile, (Custom Heart / Lung Pack), Catalog Numbers: 067350004, 067734001, 067736002. COBE Cardiovascular, Inc..

FDA Recall Z-1427-06 · Posted 2006-08-24

Recalling FirmCobe Cardiovascular, Inc
Recall StatusTerminated
Product CodeDTZ
Date Initiated2006-06-26
Date Terminated2011-08-08
Product Quantity94 units (Domestic)

Reason for Recall

Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the surface area needed for proper heat transfer.

Firm Action

Consignees were notified by letter on 06/26/2006.

Root Cause

Other

Distribution Pattern

Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013480COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATORCobe Cardiovascular, Inc. · 2001-11-16K991452COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATORCobe Cardiovascular, Inc. · 1999-10-07

Official Source

View FDA Recall →

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

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