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Terminated

Custom heart lung perfusion packs

FDA Recall Z-0265-06 · Posted 2005-12-02

Recalling FirmCobe Cardiovascular, Inc
Recall StatusTerminated
Product CodeDTM
Date Initiated2005-10-06
Date Terminated2011-08-05
Product Quantity21,512 units

Reason for Recall

One way valve in the heart lung pack assembly may be missing.

Firm Action

Consignees notified by letter on 10/06/2005.

Root Cause

Other

Distribution Pattern

Nation wide, including VA facilities in FL, NM, & CO and military facilities in CA, VA, & WA.

Official Source

View FDA Recall →

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

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