14.5F X 55cm Hemo-Flow Double Lumen Catheter, Models Hfs-55, Hft-55

• • Terminated Z-1351-2015 FDA Class II ·initiated 5 Feb 2015

  Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI (biological indicator) out of 21 on the sterilization load was out of specification.

• • Terminated Z-2693-2011 FDA Unclassified (pre-2012) ·initiated 19 May 2011

  Product was packaged with the incorrect valved peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer.

510(k) Number

K030502 ↗

FDA Product Code

MSD

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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