Hemo-Cath Silicone Double Lumen Cath SL28C & SL40C

• 4 recalls, same reason

  • Terminated Z-1149-2019 FDA Class II ·initiated 13 Mar 2019
  • Terminated Z-2217-2019 FDA Class II ·initiated 13 Mar 2019
  • Terminated Z-2216-2019 FDA Class II ·initiated 13 Mar 2019
  • Terminated Z-2215-2019 FDA Class II ·initiated 13 Mar 2019

  Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

• • Terminated Z-1083-2015 FDA Class II ·initiated 21 Jan 2015

  Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule of lidocaine, 3ml Chloraprep one-step, 10ml pre-filled saline syringe, Hygea saline wipes, and 3ml tinted Chloraprep. No injuries or illnesses were reported.

510(k) Number

K893439 ↗

FDA Product Code

LFJ

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

Manufacturer's product page: Hemo-Cath® LT

• Duo Flow Catheter-Mc 54

  Class II

  FDA 510(k) K842416 Active Cleared 26 Jul 1984

• MCSCP8PS with 'y' Hub

  Class II

  FDA 510(k) K821684 Active Cleared 24 Jun 1982

• Twin Silicone Catheter

  Class II

  FDA 510(k) K923691 Active Cleared 25 Sep 1995

• Medicomp Flexi-Smooth Wound Drainage Catheter

  Class I

  FDA 510(k) K960426 Active Cleared 21 Mar 1996

• 1.9F X 20cm Vascu-Picc 1.9F X 50cm Vascu-Picc

  Class II

  FDA 510(k) K120980 Active Cleared 2 May 2012

• Double Lumen Sublcavian-Femoral

  Class II

  FDA 510(k) K841530 Active Cleared 25 Jun 1984

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