Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
FDA Recall Z-1611-2013 · Posted 2013-06-27
Advertisement
Recalling FirmTerumo Medical Corporation
Recall StatusTerminated
Product CodeDYB
Date Initiated2013-05-30
Date Terminated2013-10-30
Product Quantity20 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement