Reported Apr 24, 2019 · Terminated
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
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 SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
- Lot codes and dates
MCAL680MCBA840MCBH140MCBK600MCBY920MCCH670MCCR320MCCV590MCDG930MCDK980MCDR400MCFB320MCFG490MCFR460MCFT410MCFY850MCFZ660MKAD410MKAN270MKAP300MKAT100MKAX320MKBA190MKBK940MKBL210MKBP450MKBV570MMAA170MMAD480MMAS020
- Amount recalled
- 6830
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.
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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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