Z-1074-2018Class II

Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b...

Name: Z-1074-2018 Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b...
Creator: Smiths Medical ASD Inc.
Published: 2017-12-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-12-04 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA)... on 2017-12-04. FDA classified it as Class II and gives the reason as "Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1074-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-04
Posted: 2018-03-15
Terminated: 2020-06-12
Recalling firm: Abbott Medical
Product: Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Customers were notified via letter on about 12/04/2017. Instructions include to examine current inventory for affected product, collect and isolate any potentially affected product, determine the total number of potentially affected product in possession and complete and return the Urgent Medical Device Recall Response Form, return any affected product on hand, and notify customers if the affected products were further distributed.
Quantity in commerce: 1,077 units total
Distribution: Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.
Product codes and lots: a. Item No. 21-4474-24 (Lot No. 87X040, 87X117); b. Item No. 21-4475-24 (Lot No. 87X044); c. Item No. 21-4477-24 (Lot No. 87X097); d. Item No. 21-8466-24 (Lot No. 87X171); e. Item No. 21-8468-24 (Lot No. 87X172, 87X244, 87X180); f. Item No. 21-8469-24 (Lot No. 87X151); g. Item No. 21-8470-24 (Lot No. 87X173, 87X254, 87X194, 87X198, 87X237)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1074-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1073-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15
Z-1074-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15

Product code LJT

K093414Class IIPort-a-Cath Power P.a.c. Implantable Venous Access SystemsSmiths Medical Asd, Inc. / cleared 2010-03-01

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)