Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
This recall has been terminated (originally issued April 16, 2014).
- Recall Initiated
- March 28, 2014
- Posted
- April 16, 2014
- Terminated
- December 12, 2014
- Recall Number
- Z-1465-2014
- Quantity
- 37 units
- Firm Location
- Ashland, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo Cardiovascular Procedure Kits
Distribution
CA
Lot / Code Info
Lot Number: RA-27
Root Cause
Labeling mix-ups
Action Taken
Terumo CVS contacted the affected user on 3/28/14 by phone via phone script to discontinue use and return all affected units in inventory. Terumo CVS will replace or issue credit for returned product.
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