FDA Recall
Terminated
PORT-A-CATH II POWER P.A.C. Low Profile" system.
Recall: Z-2499-2020
·
Initiated June 11, 2020
Recall
- Recall Number
- Z-2499-2020
- Event Number
- 85847
- Firm
- Smiths Medical ASD Inc.
- FEI Number
- 3012307300
- Product Code
- LJT
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- June 11, 2020
- Terminated
- January 25, 2021
- Address
- 6000 Nathan Ln N, Minneapolis, MN, 55442-1690
Description
PORT-A-CATH II POWER P.A.C. Low Profile" system.
Reason
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.
Action
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.
Distribution
Domestic Distribution: AR, CT, MS,TN,TX
Quantity
46 kits