FDA-Device2020-07-15Class II
PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
Smiths Medical ASD Inc.
Hazard
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.
Sold states
Domestic Distribution: AR, CT, MS,TN,TX
Affected count
46 kits
Manufactured in
6000 Nathan Ln N, Minneapolis, MN, United States
Products
PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2499-2020Don't want to check this manually?
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