Z-0271-2007

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Ref Product No. AP-01013...

Name: Z-0271-2007 Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Ref Product No. AP-01013...
Creator: Arrow International Inc
Published: 2006-09-29
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2006-09-29 / Terminated

FDA source

Arrow International Inc began a recall of Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Ref Product No. AP-01013 Latex-Free Low Profile Port on 2006-09-29. The reason FDA records is "Catheter has separated from the infusion port body". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0271-2007
Status: Terminated
Initiated: 2006-09-29
Posted: 2006-12-19
Terminated: 2007-06-04
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Ref Product No. AP-01013 Latex-Free Low Profile Port
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Catheter has separated from the infusion port body.
FDA root cause: Other
Action: The recall notification was sent out to their US customers on 9/29/2006.
Quantity in commerce: 6
Distribution: Nationwide. The firm is NOT recalling from international accounts.
Product codes and lots: Product No. AP-01013. Lot Numbers: 11284, MF3085483, MF4031500, MF4063259.

Product code LJT

K932447Class IITherex Low-Profile Port .6Mm I.d 2.3Mm O.d.Therex Corp. / cleared 1994-02-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)