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Recall Observatory FDA recall evidence

Device product

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

Z-2499-2020

June 11, 2020

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 85847
Status
Terminated
Classification
Class II
Quantity
46 kits
Official record key
device-enforcement:Z-2499-2020

Official wording

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.

Code information: Lot 3921849.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.