| Class 2 Device Recall HEMOCATH, SLX, PROPICC, VASCUPICC | |
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 | K890029 K893439 |
Product Classification |
Catheter, subclavian - Product Code LFJ
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LFJ
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