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 October 23, 2017
Create Date March 17, 2018
Recall Status1 Terminated 3 on June 21, 2018
Recall Number Z-1079-2018
Recall Event ID 79329
Product Classification Suture removal kit - Product Code MCZ
Product SUTURE REMOVAL TRAY, SET or KIT
Code Information 55160 55395 55525 60125 60255 60360 60365 75435 84105 86125 SR530  Lot codes: 2016011801 2016011290 2016022390 2016042990 2016061390 2016080390 2016101790 2017011090 2015111990 2017022790 2015062201 2015081001 2016032101 2016050901 2016091201 2017032001 2017061501 2015042701 2015100501 2015120701 2016011101 2016071101 2016103101 2017011601 2017071201 2015100501 2016012501 2016071101 2016090501 2017013101 2017021601 2017051101 2017080701 2016060601 2017071101 2015111601 2016030701 2016101001 2015062201 2015110201 2016022201 2016091201 2015050401 2015082401 2016010401 2016072501 2017042401 2016101001 2017021301 2017071101 2016050201 2016111401 2015062901 2015081701 2015090701 2015110201 2016021501 2016040401 2016071101 2016102401 2016121401 2017021301 2017041901 2017070501 2017071801 2015072001 2016111401 2016021501 2016062001 2016081501 2016062701 2016040790 2015102990 2015120790 2016011890 2016050990 2016072590 2016091990 2017010390 2017012390 2017052290 2017062290 2015061501 2015081001 2015102601 2015122801 2016030701 2016050901 2016072501 2016101001 2016122701 2017041201 2017071001 2015060801 2015072001 2015082401 2015102601 2015122801 2016022201 2016050201 2016072501 2016091201 2016110701 2017022801 2017053101 2017060501 2016122001 2017041101 
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
Manufacturer Reason
for Recall		 Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On October 16, 2017 a PRODUCT CORRECTION letter was issued to customers notifying them that if they had any kits in their inventory, Centurion will supply labels to affix to the front of each kit instructing the user to discard the prep pad upon opening the kit. Other components of the kit may continue to be used and are NOT within the scope of this recall.
Distribution Nationally
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.
-
-