Z-1611-2013 Class II Terminated
FDA device recall Z-1611-2013 was initiated by Terumo Medical Corporation on May 30, 2013 and is designated Class II. Reason for recall: Medical devices were incorrectly labeled with extended expiration dates. The recall status is terminated (terminated October 30, 2013). Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2013
- Initiation Date
- May 30, 2013
- Termination Date
- October 30, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
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.
Reason for Recall
Medical devices were incorrectly labeled with extended expiration dates.
Distribution Pattern
Nationwide Distribution.
Code Information
Lot MM27