Recalls / —
—#181896
Product
PORT-A-CATH II POWER P.A.C. Low Profile" system.
- FDA product code
- LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K072657
- Affected lot / code info
- Lot 3921849.
Why it was recalled
Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- Domestic Distribution: AR, CT, MS,TN,TX
Timeline
- Recall initiated
- 2020-06-11
- Terminated
- 2021-01-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #181896. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.