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/
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Advanced Medical Solutions McKesson calcium alginate sheet dressings (4"x8", catalog #3563) that were distributed nationwide. The recall involves multiple lots of the product received between June 1, 2021 and September 30, 2021. These dressings were exposed to higher-than-appropriate temperatures at a facility between June and August 2021 prior to delivery, which may have affected product effectiveness.
The manufacturer has determined that this specific temperature deviation is not likely to cause adverse health consequences. The recall notice does not specify a remedy or recommended action for consumers who may have affected product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide distribution. Quantity: 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 Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.