Recalls / —
—#165032
Product
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
- FDA product code
- OEZ — Cardiovascular Procedure Kit
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- Lot Number: VE17
Why it was recalled
Kit was labeled with the incorrect Expiration Date of April 30, 2019.
Root cause (FDA determination)
Incorrect or no expiration date
Action the firm took
On May 12, 2017 Terumo Cardiovascular Systems Corporation telephoned their one client and notified them of the labeling error and asked them to hold product. All product was immediately quarantined.
Recalling firm
- Firm
- Terumo Cardiovascular Systems Corp
- Address
- 28 Howe St, Ashland, Massachusetts 01721-1305
Distribution
- Distribution pattern
- US state of FL
Timeline
- Recall initiated
- 2017-05-12
- Terminated
- 2018-10-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #165032. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.