Cobe Cardiovascular, Inc Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone systems), Catalog numbers:050125400, 050502000. COBE Cardiovascular, Inc.. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone systems), Catalog numbers:050125400, 050502000. COBE Cardiovascular, Inc..
Brand
Cobe Cardiovascular, Inc
Lot Codes / Batch Numbers
Catalog # 050125400, Lot Numbers: 0610800081, 0613600060, 0614400061....Catalog # 050502000, Lot number 0612200145.
Products Sold
Catalog # 050125400, Lot Numbers: 0610800081, 0613600060, 0614400061....Catalog # 050502000, Lot number 0612200145.
Cobe Cardiovascular, Inc is recalling Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone systems), Catalo due to 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 t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consignees were notified by letter on 06/26/2006.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, GA, IN, MO, VA
Page updated: Jan 10, 2026