FDA recall Z-2499-2020

Product

PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.

Reason for recall

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.

Distribution

Domestic Distribution: AR, CT, MS,TN,TX

Key facts

Status

Terminated

Initiation date

2020-06-11

Report date

2020-07-15

Termination date

2021-01-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2499-2020