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 CaviBleach Wipes

  • 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 CaviBleach Wipes see related information
Date Initiated by Firm December 02, 2009
Date Posted June 22, 2010
Recall Status1 Terminated 3 on June 23, 2010
Recall Number Z-1815-2010
Recall Event ID 55051
Product Classification Disinfectant, medical devices - Product Code LRJ
Product CaviBleach Wipes; a disinfectant medical device, active ingredient Sodium hypochlorite 0.525%; a single 9" x 9" towelette, pre-moistened with 0.525% - 0.656% sodium hypochlorite, packaged in a flexible poly foil pouch, 50 wipes per dispenser box, 8 boxes per case; Manufactured for Metrex Research Corporation, 28210 Wick Road, Romulus, MI 48174.

General purpose disinfectant wipe for hard, non-porous surfaces, patient care equipment and point of care equipment.
Code Information Reorder No. 10-1155, LotF29, Exp June 2010
Recalling Firm/
Manufacturer		 Medtrol, Inc.
7157 N Austin Ave
Niles IL 60714-4617
For Additional Information Contact Mr. Paul W. Stiffler, Ph.D.
800-647-7180
Manufacturer Reason
for Recall		 The disinfectant wipes were found out of specifications for the disinfectant activity prior to the expiration date.
FDA Determined
Cause 2		 Process control
Action Medtrol telephoned Metrex on December 2, 2009, informing them that Medtrol was requesting the recall of the affected product. Metrex sent Urgent Medical Device Recall letters dated December 3, 2009 to their accounts, requesting them to examine their inventory for the affected product, and return any found for credit. They also requested their accounts to sub-recall the product to the retail level. Metrex also requested their accounts to complete and return the enclosed reply sheet, acknowledging receipt of the recall letter and indicating the amount of product being returned. For further information, contact Metrex Customer Care Center at 1-800-841-1428.
Quantity in Commerce 150 cases
Distribution Nationwide Distribution -- Including state of Michigan.
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.
-
-