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Medical Components, Inc dba MedComp recalls Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX D
Recalled February 18, 2015 · FDA recall Z-1083-2015 · Medical Components, Inc
Hazard
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. · FDA Class II
Units
243
Sold at
US Nationwide Distribution
Description
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.
Product
Hemodialysis Catheters and PICCs: Product 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 uses: To 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.
Manufacturer(s)
Medical Components, Inc dba MedComp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →