LifePort, Dual Lumen Profile Plastic Dual Port with Poly… recallZ-0256-05 · Horizon Medical Products Inc · initiated Sep 20, 2004
Terminated All recalls posted in November 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Horizon Medical Products Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
Consignees were notified by letter on 09/20/2004.
Recall details
- Recall number
- Z-0256-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 20, 2004
- Posted by the FDA
- Nov 24, 2004
- Recalling firm
- Horizon Medical Products Inc
- Quantity
- 44 kits
- Product code
- LJT
- FDA submissions
- K953529
- Distribution
- FL, GA, LA, MD, NJ, OK, TX, VA
Product description
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.
Code information (models, lots, serial numbers)
Catalog #LPS 7255, Lot #20474
Other devices under the same FDA submission
1 device cleared under K953529 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Lifeport LPS5057Navilyst Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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