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Terminated

Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt

FDA Recall Z-1009-04 · Posted 2004-07-20

Recalling FirmCobe Cardiovascular, Inc
Recall StatusTerminated
Product CodeDTN
Date Initiated2004-05-25
Date Terminated2005-03-31
Product Quantity216 sets

Reason for Recall

Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia.

Firm Action

Customers were notified by telephone on 5/25/2004 and by letter on 6/3/2004.

Root Cause

Other

Distribution Pattern

AL, AZ, FL, KS, MN, MO, NV, TX, WI. Foreign distribution to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K934847NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMSSorin Biomedical, Inc. · 1994-04-15

Official Source

View FDA Recall →

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

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