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U.S. Department of Health and Human Services

Class 2 Device Recall METREX RESEARCH CORP

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  Class 2 Device Recall METREX RESEARCH CORP see related information
Date Initiated by Firm May 25, 2022
Date Posted August 26, 2022
Recall Status1 Open3, Classified
Recall Number Z-1620-2022
Recall Event ID 90336
Product Classification Disinfectant, medical devices - Product Code LRJ
Product a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000.
b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008.
c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL MX-1000 METREX Catalog #13-1000.
d. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE PUMP SPRAY 24OZ METREX Catalog #13-1024.
e. CaviCide1 DISINFECTANT, CLNR CAVICIDE1 24OZ (12/CS) METREX Catalog #13-5024.
f. METREX RESEARCH CORP DISINFECTANT, ENVIROCIDE 24OZ(12/CS) METREX Model Number: 13-3324.
g. METREX RESEARCH CORP Envirocide DISINFECTANT, ENVIROCIDE GL(4/CS)MX-3300 METREX Model Number: 13-3300
Code Information GTIN: a. 00615375005446; H97113500020. b. 00615375005309; H97113100824. c. 00615375005385; H9711310002. d. 00615375005361, H97113102422. e. 00615375005415, H97113502426. f. 00615375005354; H97113332427. g. 00615375005378; H113330021
Recalling Firm/
Manufacturer		 Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233
For Additional Information Contact Ms. Ruby Upadhyaya
804-553-2281
Manufacturer Reason
for Recall		 Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
FDA Determined
Cause 2		 Environmental control
Action Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 sedgwick@sedgwick.com. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. ¿ This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent possible patient harm. ¿ Please complete and return the enclosed response form as soon as possible even if you do not have any product on hand. ¿ Customers should contact Sedgwick directly by phone at 1-888-943-2401 to return the recalled products or if they have additional questions regarding this notification. Representatives are available Monday Friday, 8:00 am 5:00 pm PT
Quantity in Commerce 50cs b. 38 c. 519gal d. 1671 e. 43.25cs f. 33btl g. unk
Distribution US Nationwide
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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