Reported Aug 14, 2019 · Terminated
14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for…
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 · 19438-2936
Is this the product you have?
- 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No
- MC061424 Product UsageAn aid for introducing a hemodialysis catheter
- Lot codes and dates
MCAL430MCAT000MCBM770MCBS380MCCC840MCCM930MCCS360MCCZ450MCDC580MCDN120MCDR420MCFB350MCFG980MCFM410MCFP230MCFT430MCFZ290MKAF350MKAG490MKAM210MKAR120MKBA200MKBL090MKBL220MKBV580MMAB710MMAM070MMAQ950
- Amount recalled
- 6830
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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