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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson

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  Class 2 Device Recall McKesson see related information
Date Initiated by Firm May 25, 2022
Date Posted August 26, 2022
Recall Status1 Open3, Classified
Recall Number Z-1614-2022
Recall Event ID 90336
510(K)Number K931052  K930284  
Product Classification Sterilant, medical devices - Product Code MED
Product a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800.
b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400.
c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5% 28DAY QT (16/CS) PSS744 Catalog # 341.
d. METREX RESEARCH LLC MetriCide DISINFECTANT, METRICIDE 14DAYGLUTARALDEHYDE 1GL (4/CS) Catalog # 10-1400.
e. METREX RESEARCH LLC MetriCide28 DISINFECTANT, METRICIDE GLUT LNG LIFE GL (4GL/CS) Catalog # 10-2800
Code Information GTIN: a. 10612479150581; 40612479150599 CS. b. 10612479150567; 40612479150575 CS. c. 10612479204406; 40612479204414. d. 00615375005453; 10615375005450 CS; H9711014002. e. 00615375005477; 10615375005474 CS; H97110280022
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 28 gallons b. 38 gal c. 16 qt d. 40 gal e. 124 gal
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.
510(K) Database 510(K)s with Product Code = MED and Original Applicant = METREX RESEARCH CORP.
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