Retiro De Equipo (Recall) de LifePort¿, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255

Catalog #LPS 7255, Lot #20474

General Hospital and Personal Use Devices

2

Yes

FL, GA, LA, MD, NJ, OK, TX, VA

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.