Cobe Cardiovascular, Inc Custom heart lung perfusion packs Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Custom heart lung perfusion packs
Brand
Cobe Cardiovascular, Inc
Lot Codes / Batch Numbers
210 unique catalog numbers with 779 unique lot numbers.
Products Sold
210 unique catalog numbers with 779 unique lot numbers.
Cobe Cardiovascular, Inc is recalling Custom heart lung perfusion packs due to One way valve in the heart lung pack assembly may be missing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
One way valve in the heart lung pack assembly may be missing.
Recommended Action
Per FDA guidance
Consignees notified by letter on 10/06/2005.
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
CA, CO, FL, IN, NM, VA, WA
Page updated: Jan 10, 2026