Medical Components, Inc dba MedComp: Medical Device Recall in 2015 - (Recall #: Z-1351-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and short term hemodialysis catheters and infusion catheters.

Product Classification:

Class II

Date Initiated: February 5, 2015

Date Posted: April 8, 2015

Recall Number: Z-1351-2015

Event ID: 70472

Reason for Recall:

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.

Status: Terminated

Product Quantity: 3152

Code Information:

Medcomp products:Catalog Code/ Lot Number/Expiration Date: DFXL148MTE/ MGMC610/10/31/2019; HFS 32/ MGMB440/ 07/14/2017; HFS24E./MGLY830/07/31/2017; MC061402/MGMD190/07/15/2017; MC3L-8S/MGMD920/10/16/2019; MR17035211/MGMD680/10/31/2017; TRAY #593-3/MGMB460/07/15/2017; RMS23602/MBWM930/07/31/2017; ASPC2816-3/MBWM900/07/31/2017; Tray #55216-3/MBWL780/07/31/2017; ASPC2816-3PC/MBWX290/07/31/2017; 10301207/MGMD930/07/31/2017; 10800701/ MGLY730/ 07/31/2017; 10800702/ MGMD210/ 07/31/2017; 10800703/MGLY740/07/31/2017 AngioDynamics products- model numbers/lot numbers/ expiration dates: 10301207/MGMD930/07/31/2017; 10800701/MGLY730/07/31/2017; 10800702/MGMD210/07/31/2017; 10800703/MGLY740/07/31/2017

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated