Reported Apr 8, 2015 · Terminated
Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split…
Medical Components, Inc. dba MedComp
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medical Components, Inc dba MedComp · 1499 Delp Dr · Harleysville, PA · 19438
Is this the product you have?
- 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.
- Lot codes and dates
18 of 18 products
Products covered by this recall # Product as published 1 Medcomp products:Catalog Code/ Lot Number/Expiration Date: DFXL148MTE/ MGMC610/10/31/2019 2 HFS 32/ MGMB440/ 07/14/2017 3 HFS24E./MGLY830/07/31/2017 4 MC061402/MGMD190/07/15/2017 5 MC3L-8S/MGMD920/10/16/2019 6 MR17035211/MGMD680/10/31/2017 7 TRAY #593-3/MGMB460/07/15/2017 8 RMS23602/MBWM930/07/31/2017 9 ASPC2816-3/MBWM900/07/31/2017 10 Tray #55216-3/MBWL780/07/31/2017 11 ASPC2816-3PC/MBWX290/07/31/2017 12 10301207/MGMD930/07/31/2017 13 10800701/ MGLY730/ 07/31/2017 14 10800702/ MGMD210/ 07/31/2017 15 10800703/MGLY740/07/31/2017 AngioDynamics products- model numbers/lot numbers/ expiration dates: 10301207/MGMD930/07/31/2017 16 10800701/MGLY730/07/31/2017 17 10800702/MGMD210/07/31/2017 18 10800703/MGLY740/07/31/2017 - Amount recalled
- 3152
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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