Z-0256-05

LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255...

Name: Z-0256-05 LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255...
Creator: Horizon Medical Products Inc
Published: 2004-09-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-09-20 / Terminated

FDA source

Horizon Medical Products Inc began a recall of LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc... on 2004-09-20. The reason FDA records is "The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0256-05
Status: Terminated
Initiated: 2004-09-20
Posted: 2004-11-24
Terminated: 2005-03-01
Recalling firm: Boston Scientific Corporation
Product: LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816.The devices are placed in a molded PVC tray. The tray is sealed with a Tyvek lid. The inner sealed tray is then placed in another tray, the Instruments for Use (IFU), Patient Information Booklet (PIB), patient ID card and its label, the IFU for the locking mechanism and the labeling describing the materials and priming volume, are all placed on top of that lid before sealing the outer tray with another Tyvek lid. The product label is applied to the outer tray lid and the entire package-tray inside a tray is then sterilized. The primary sterile barrier is the inner sealed tray.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer.
FDA root cause: Other
Action: Consignees were notified by letter on 09/20/2004.
Quantity in commerce: 44 kits
Distribution: FL, GA, LA, MD, NJ, OK, TX, VA
Product codes and lots: Catalog #LPS 7255, Lot #20474

Product code LJT

K953529Class IIStrato/infusaid Life & Infuse-a-Port Implantable Port SystemStrato/Infusaid, Inc. / cleared 1996-01-26

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)