Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
FDA device recall Z-1465-2014 · posted 2014-04-16 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo Cardiovascular Procedure Kits
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- OEZ
- Quantity affected
- 37 units
- Distribution
- CA
- Date initiated
- 2014-03-28
- Date posted
- 2014-04-16
- Date terminated
- 2014-12-12
- Location
- Ashland, MA
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