is it on recall

Recall archive / FDA device enforcement

a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563. b. ADVAN... — FDA record Z-1805-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Reason
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.
Classification
Class III
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
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
Agency-reported status
Ongoing
Source record identifier
Z-1805-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityGTIN: 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

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Oct 5, 2022
Recall initiation date
May 25, 2022
Center classification date
Sep 26, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

Related records

Medical devices recordsMckesson Medical-Surgical Inc. Corporate Office records