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U.S. Department of Health and Human Services

Class 2 Device Recall HEMOCATH, SLX, PROPICC, VASCUPICC

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  Class 2 Device Recall HEMOCATH, SLX, PROPICC, VASCUPICC see related information
Date Initiated by Firm January 21, 2015
Date Posted February 10, 2015
Recall Status1 Terminated 3 on August 03, 2015
Recall Number Z-1083-2015
Recall Event ID 70351
510(K)Number K893439  K890029  
Product Classification Catheter, subclavian - Product Code LFJ
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.
Code Information Lot numbers: MBWK970, MBWH890, MBWJ180, MBWJ460, MBWH910, MBWH940   
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438
For Additional Information Contact Customer Support
215-256-4201
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Process control
Action Medcomp sent a Product Alert/Recall letter dated January 21, 2015 to customers via email. The letter identified the affected product, problem and actions to be taken. Medcomp requested the return of all affected product. Customers were instructed to contact their customer service representative for instructions for returning the product.
Quantity in Commerce 243
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LFJ and Original Applicant = MEDICAL COMPONENTS, INC.
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