Recalls / —
—#126616
Product
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
- FDA product code
- OEZ — Cardiovascular Procedure Kit
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- Lot Number: RA-27
Why it was recalled
Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo Cardiovascular Procedure Kits
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
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.
Recalling firm
- Firm
- Terumo Cardiovascular Systems Corp
- Address
- 28 Howe St, Ashland, Massachusetts 01721-1305
Distribution
- Distribution pattern
- CA
Timeline
- Recall initiated
- 2014-03-28
- Posted by FDA
- 2014-04-16
- Terminated
- 2014-12-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #126616. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.