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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 April 16, 2019
Recall Status1 Terminated 3 on March 05, 2024
Recall Number Z-1149-2019
Recall Event ID 82415
510(K)Number K893439  
Product Classification Catheter, subclavian - Product Code LFJ
Product 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Code Information MCAL680 MCBA840 MCBH140 MCBK600 MCBY920 MCCH670 MCCR320 MCCV590 MCDG930 MCDK980 MCDR400 MCFB320 MCFG490 MCFR460 MCFT410 MCFY850 MCFZ660 MKAD410 MKAN270 MKAP300 MKAT100 MKAX320 MKBA190 MKBK940 MKBL210 MKBP450 MKBV570 MMAA170 MMAD480 MMAS020 
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438-2936
For Additional Information Contact
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		 Finished device 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 Distributed to accounts in 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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