Date Initiated by Firm | May 25, 2022 |
Date Posted | September 26, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1805-2022 |
Recall Event ID |
90731 |
510(K)Number | K090453 |
Product Classification |
Dressing, wound, drug - Product Code FRO
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Product | a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563.
b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AG2X2" (10/BX 10BX/CS) Catalog #3557.
c. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGSHEET 4"X4.75" (10/BX) Catalog #3558.
d. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGSHEET 4"X8" (5/BX 10 Catalog #3559.
e. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGROPE 3/4"X12" (5/BX 10BX/CS) Catalog #3560.
f. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 2"X2" (10/BX 10BX/C Catalog #3561.
g. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X4.75" (10/BX 1 Catalog #3562.
h. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS) Catalog #3563.
i. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE ROPE 3/4"X12" (5/BX 10BX/CS) Catalog #3564.
j. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, SKIN FOLD MGMNT AG 10"X144" (1/BX 12BX/CS) Catalog #16-10144R |
Code Information |
GTIN:
a. 00612479193901; 00612479193918 CS; 00612479193895 EA. b. 00612479193710; 00612479193727; 00612479193734 Case. c. 00612479193741; 00612479193765; 00612479193758. d. 00612479193789; 00612479193796 CS; 00612479193772 EA e. 00612479193802; 00612479193819; 00612479193826. f. 00612479193840; 00612479193857 CS; 00612479193833 EA. g. 00612479193871; 00612479193888 CS; 00612479193864 EA. h. 00612479193901; 00612479193918 CS; 00612479193895 EA. i. 00612479193932; 00612479193949 CS; 00612479193925 EA.
j. unknown |
Recalling Firm/ Manufacturer |
Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233
|
For Additional Information Contact | 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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences. |
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. 131.2 boxes b. 85.7 c. 51.2 d. 92 e. 4 f. 56 g. 644.7 h. 131.2 i. 222 j. 1 |
Distribution | US Nationwide distribution. |
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.
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510(K) Database | 510(K)s with Product Code = FRO
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