Z-1351-2015Class II

Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated...

Name: Z-1351-2015 Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated...
Creator: Medical Components, Inc dba MedComp
Published: 2015-02-05
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2015-02-05 / Terminated / root cause: manufacturing process

FDA source

Medical Components, Inc dba MedComp began a recall of Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III... on 2015-02-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1351-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-05
Posted: 2015-03-30
Terminated: 2015-08-06
Recalling firm: Medical Components, Inc.
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 devices packaged-long and short term hemodialysis catheters and infusion catheters.
Product code: MSD Catheter, Hemodialysis, Implanted
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On or about 02/03/2015, Medcomp sales representatives notified the affected medical facilities and providing Medcomp's recall letter. This was accomplished by e-mail, telephone, or visit. Distributors for the international accounts were notified by Medcomp via e-mail. A copy of Medcomp's recall letter was attached. For AngioDynamics product- Medcomp notified AngioDynamics by e-mail of the product recall. Every consignee was requested to complete and return Page 2 of the recall letter verifying receipt of the recall and disposition of the product they received. AngioDynamics was requested to provide an account of the disposition for the total number of product they received.
Quantity in commerce: 3152
Distribution: Worldwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1351-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1351-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-30

Product code MSD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)