Z-1465-2014 Class II Terminated
FDA device recall Z-1465-2014 was initiated by Terumo Cardiovascular Systems Corp on March 28, 2014 and is designated Class II. Reason for recall: Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits The recall status is terminated (terminated December 12, 2014). Affected quantity: 37 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2014
- Initiation Date
- March 28, 2014
- Termination Date
- December 12, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37 units
Product Description
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Reason for Recall
Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits
Distribution Pattern
CA
Code Information
Lot Number: RA-27