Date Initiated by Firm |
May 25, 2022 |
Date Posted |
August 26, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1583-2022 |
Recall Event ID |
90336 |
510(K)Number |
K183255 K093243
|
Product Classification |
Test, time, prothrombin - Product Code GJS
|
Product |
a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50.
b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No. 03P69-10. |
Code Information |
a. GTIN: 00861900000336; 10861900000395; 00861900000398. Lot codes distributed between 5/30/2021 - 8/24/2021.
b. GTIN 00861900000343 Lots Distributed: 8/20/2021 - 8/20/2021 |
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 |
a. 27 boxes b. 1 box |
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 = GJS and Original Applicant = COAGUSENSE, INC 510(K)s with Product Code = GJS and Original Applicant = CoaguSense, Inc.
|