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Terminated

Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431

FDA Recall Z-1465-2014 · Posted 2014-04-16

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeOEZ
Date Initiated2014-03-28
Date Terminated2014-12-12
Product Quantity37 units

Reason for Recall

Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo Cardiovascular Procedure Kits

Firm Action

Terumo CVS contacted the affected user on 3/28/14 by phone via phone script to discontinue use and return all affected units in inventory. Terumo CVS will replace or issue credit for returned product.

Root Cause

Labeling mix-ups

Distribution Pattern

CA

Official Source

View FDA Recall →

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

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