Reported Feb 18, 2015 · Terminated
Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX…
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?
- Hemodialysis Catheters and PICCsProduct
- identification
MCDLTSL24P (SF X 24CM LT HEMO-CATH)MC061422 (14FX15CM SLX DBL LMN ST CATH)MRCTP41017 (4F X 55CM SINGLE CT PICC)MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY)MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY)MR81013106MB (3FX60CM SGL TAPRLS VASCU-PICC)
- Intended usesTo attain long-term vascular access for hemodialysis and apheresis. The Medcomp SLX Silicone Double Lumen Catheter is designed for acute hemodialysis and apheresis. The Pro-PICC¿ CT catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The Peripherally Inserted Central Vein Access Catheters are designed for Long or Short- Term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring
- Lot codes and dates
- Lot numbers
MBWK970MBWH890MBWJ180MBWJ460MBWH910MBWH940
- Lot numbers
- Amount recalled
- 243
Where it was sold
- Nationwide
Why it was recalled
Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule of lidocaine, 3ml Chloraprep one-step, 10ml pre-filled saline syringe, Hygea saline wipes, and 3ml tinted Chloraprep. No injuries or illnesses were reported.
This product could cause temporary or reversible health problems — stop using it.
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