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.
This recall has been terminated (originally issued June 27, 2013).
- Company
- Terumo Medical Corporation
- Recall Initiated
- May 30, 2013
- Posted
- June 27, 2013
- Terminated
- October 30, 2013
- Recall Number
- Z-1611-2013
- Quantity
- 20 units
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Medical devices were incorrectly labeled with extended expiration dates.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot MM27
Root Cause
Error in labeling
Action Taken
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.
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