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U.S. Department of Health and Human Services

Class 2 Device Recall 14F SLX Double Lumen Full Tray

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  Class 2 Device Recall 14F SLX Double Lumen Full Tray see related information
Date Initiated by Firm March 13, 2019
Create Date August 08, 2019
Recall Status1 Terminated 3 on March 05, 2024
Recall Number Z-2217-2019
Recall Event ID 83324
510(K)Number K893439  
Product Classification Catheter, subclavian - Product Code LFJ
Product 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425

Product Usage: An aid for introducing a hemodialysis catheter
Code Information MCAM240 MCBL480 MCBS870 MCCF480 MCCJ320 MCCW690 MCCZ500 MCFG830 MCFR160 MCFS760 MCFZ360 MKAJ330 MKAR130 MKBL500 MKBX060 MMAB730
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438-2936
For Additional Information Contact Customer service
215-256-4201
Manufacturer Reason
for Recall		 Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
FDA Determined
Cause 2		 Labeling Change Control
Action On March 13, 2019, the firm notified customers via Urgent Medical Device Recall letter. Customers were informed that the kits contain a 15F "non-valved" peelable introducer despite the label indicating that the kit is packaged with a "valved" introducer. Customers were asked to do the following: 1. Immediately examine your inventory and quarantine product subject to recall. 2. If you have further distributed this product, please identify your customers and immediately notify them of the recall. 3. Contact your Medical Components, Inc. customer service representative for a Returned Goods Authorization (RGA) number if you have product to return. The phone number to call is 215-256-4201. 4.Complete and return the Medical Device Recall Return Response Form. The form can be returned by fax (215-256-9191) or email (recalls@medcompnet.com). Contact Information for questions: Monday through Friday, 8:00 AM to 4:00 PM, Eastern Standard Time. Phone: 215-256-4201; Email: recalls@medcompnet.com
Quantity in Commerce 6830
Distribution US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
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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