The Recall Desk
HighFDA (Devices)·Z-1351-2015·Announced 2015-04-08

Medcomp Recalls Catheter Insertion Kits Due to Sterilization Defect

Medcomp is recalling specific catheter insertion kits because one biological indicator failed during the sterilization process, potentially compromising sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a potential sterilization failure in a medical device, which poses a risk of infection (risk-of-harm product), but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Medical Components, Inc. dba MedComp has initiated a recall of specific catheter insertion kits used to implant various hemodialysis and infusion catheters. The affected products include Medcomp Duo-Flow 400XL, Hemo-Flow, SLX, Triple Lumen Infusion, CT rated PICC, Split Cath III, and PC Split Cath III, as well as AngioDynamics Dura-Flow and Schon XL catheters. The recall involves 3,152 units that were distributed worldwide.

The recall was initiated because the product shipped was out of specification. Specifically, one biological indicator (BI) out of 21 on the sterilization load was out of specification. This failure suggests that the sterilization process may not have been fully effective for the affected lots.

Healthcare facilities and distributors should identify the affected lots using the catalog codes, lot numbers, and expiration dates provided in the recall notice. Users should stop using the affected insertion kits and contact MedComp for instructions on return or replacement. No illnesses or injuries have been reported in the source text.

The recalled product

Product
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 device
Manufacturer
Medical Components, Inc dba MedComp
Category
Medical Device — Catheters
Hazard
Affected units
3,152

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • 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
  • 10800701/MGLY730/07/31/2017
  • 10800702/MGMD210/07/31/2017
  • 10800703/MGLY740/07/31/2017

Distribution

Distribution scope not specified by the agency.

Related recalls

Same manufacturer · Medical Components, Inc dba MedComp

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Same hazard · sterilization failure

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