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Terminated

Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222

FDA Recall Z-0966-2019 · Posted None

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeOEZ
Date Initiated2018-12-20
Date Terminated2019-08-20
Product Quantity12 packs

Reason for Recall

Presence of natural rubber latex is not declared in the label

Firm Action

Terumo issued Urgent Medical Device Recall dated 12/20/18 stating reason for recall, health risk and an appropriate course of action for the return of affected product to Terumo. Questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET.

Root Cause

Component design/selection

Distribution Pattern

TX

Official Source

View FDA Recall →

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

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