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Terminated

Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.

FDA Recall Z-1612-2013 · Posted 2013-06-27

Recalling FirmTerumo Medical Corporation
Recall StatusTerminated
Product CodeDYB
Date Initiated2013-05-30
Date Terminated2013-10-30
Product Quantity550 units

Reason for Recall

Medical devices were incorrectly labeled with extended expiration dates.

Firm Action

The recalling firm notified consignees by letter on 5/30/2013. The letter was flagged as an urgent product bulletin addressed to risk managers. The notification advised customers to immediately discontinue use and quarantine any available stock for subsequent instructions to be provided for pick-up and replacement.

Root Cause

Error in labeling

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102008GLIDESHEATHTerumo Medical Corp. · 2010-07-21

Official Source

View FDA Recall →

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

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