Recall Z-1805-2022
Mckesson Medical-Surgical Inc. Corporate Office · initiated May 25, 2022
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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
Codes / lots: 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
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: Environmental control
Action taken
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
Details
- Recall number
- Z-1805-2022
- Initiated
- May 25, 2022
- Posted by FDA
- September 26, 2022
- Product code
- FRO – Dressing, Wound, Drug
- 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
- Distribution
- US Nationwide distribution.
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1787-2022 Class III | DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1788-2022 Class III | a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1789-2022 Class III | DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1790-2022 Class III | a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas /…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1791-2022 Class III | SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1792-2022 Class III | a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1793-2022 Class III | a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1794-2022 Class III | a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1795-2022 Class III | Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560.Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1796-2022 Class III | a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen /…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1797-2022 Class III | MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1798-2022 Class III | a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1799-2022 Class III | a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219.…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1800-2022 Class III | a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1801-2022 Class III | Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1802-2022 Class III | Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1803-2022 Class III | Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1804-2022 Class III | a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1806-2022 Class III | a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4"…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1807-2022 Class III | 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1808-2022 Class III | a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b.…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1809-2022 Class III | a. DYNAREX Nice'n Fresh WIPE, BABY WET 6X6.75" (140/CN12CN/CS) Catalog # 1313. b.…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |