Medical Components, Inc dba MedComp: Medical Device Recall in 2015 - (Recall #: Z-1083-2015)
See the recall detail below. You can also see other recalls from the same firm in 2015.
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.
Class II
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.
Lot numbers: MBWK970, MBWH890, MBWJ180, MBWJ460, MBWH910, MBWH940
US Nationwide Distribution
Voluntary: Firm initiated