| Date Initiated by Firm | May 25, 2022 |
|---|
| Date Posted | August 26, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1614-2022 |
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| Recall Event ID |
90336 |
| 510(K)Number | K930284 K931052 |
|---|
| 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
|
| FEI Number |
3004386693
|
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 |
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| Distribution | US Nationwide |
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| Total Product Life Cycle | TPLC Device Report |
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|
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
|
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