Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall see related information
Date Initiated by Firm July 27, 2020
Create Date September 06, 2020
Recall Status1 Terminated 3 on April 30, 2021
Recall Number Z-2940-2020
Recall Event ID 86163
510(K)Number K994105  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product Medcomp 15.SF X 24CM Titan HD CATHETER
(CUFF 19CM FROM TIP)
Ref: THD155024
Code Information Lot # MPCT670, UDI 884908129304 Exp. Date 12/20/2020  
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438-2936
For Additional Information Contact SAME
215-256-4201
Manufacturer Reason
for Recall		 Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
FDA Determined
Cause 2		 Under Investigation by firm
Action Medcomp issued Urgent Medical Device Recall letter issued first class mail to the customers on July 27, 2020. Letter states reason for recall, health risk and action to take: " Immediately examine your inventory and quarantine all product subject to recall. " Options for disposition of affected product: o Return the product to Medcomp - Contact your Medical Components, Inc. customer service representative for a Returned Goods Authorization {RGA) number. The phone number to call is 215-256-4201. o Have individually packaged and sterilized 16F peelable introducers (MR191603) sent to use with the kits. Call your customer service representative and provide the number of kits you need the replacements introducers for. Same number as above. " Complete and return the Medical Device Recall Product Disposition 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 132 eaches
Distribution AZ, CA. FL. GA, NC, ND, NJ, NY, OH, PA, VA, WA
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 = MSD and Original Applicant = MEDICAL COMPONENTS, INC.
-
-