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Terminated

Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.

FDA Recall Z-0960-03 · Posted 2003-07-02

Recalling FirmCobe Cardiovascular, Inc
Recall StatusTerminated
Product CodeDTN
Date Initiated2003-05-09
Date Terminated2003-07-08
Product Quantity60 units

Reason for Recall

Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.

Firm Action

All consignees were contacted by telephone on 05/09/2003, followed by a letter.

Root Cause

Other

Distribution Pattern

MN, NE, OK

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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