FDAClass IIJuly 15, 2020

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

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

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 3921849.

Product
PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
Recalling firm
Smiths Medical ASD Inc.
Quantity
46 kits
Distribution
Domestic Distribution: AR, CT, MS,TN,TX
Recall date
July 15, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls