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Terminated

Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ Hospital***, Item # 71305-03

FDA Recall Z-2615-2010 · Posted 2010-09-29

Recalling FirmTerumo Cardiovascular Corporation
Recall StatusTerminated
Product CodeDTR
Date Initiated2010-06-08
Date Terminated2012-02-29
Product Quantity110 kits

Reason for Recall

Medical device vent port may be occluded and prevent delivery of priming fluid.

Firm Action

Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 2010.

Root Cause

Equipment maintenance

Distribution Pattern

The products were distributed nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K900640MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU3M Company · 1990-04-20

Official Source

View FDA Recall →

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

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