Z-2499-2020Class II

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

Name: Z-2499-2020 PORT-A-CATH II POWER P.A.C. Low Profile" system
Creator: Smiths Medical ASD Inc.
Published: 2020-06-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-06-11 / Terminated / root cause: packaging

FDA source

Smiths Medical ASD Inc. began a recall of PORT-A-CATH II POWER P.A.C. Low Profile" system on 2020-06-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2499-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-11
Posted: 2020-07-04
Terminated: 2021-01-25
Recalling firm: Abbott Medical
Product: PORT-A-CATH II POWER P.A.C. Low Profile" system.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
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.
Quantity in commerce: 46 kits
Distribution: Domestic Distribution: AR, CT, MS,TN,TX
Product codes and lots: Lot 3921849.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2499-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2499-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04

Product code LJT

K072657Class IIPower Port-a-Cath, Cath II, and P.a.s. Port T2 Power P.a.c. Implantable Venous Access Systems and Power Gripper PlusSmiths Medical MD, Inc. / cleared 2007-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)