Z-1799-2022 Class III Ongoing
FDA device recall Z-1799-2022 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on May 25, 2022 and is designated Class III. 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… The recall status is ongoing. Affected quantity: a. 17 b. 7 c. 1 d. 2 e. 5.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 5, 2022
- Initiation Date
- May 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a. 17 b. 7 c. 1 d. 2 e. 5
Product Description
a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ2 1" 50YDS Catalog # GL-220. c. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ4 25/8" 50YDS Catalog # GL-222. d. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE WHT W/O APPL 5/8"X50YDS Catalog # GL-241. e. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE WHT W/O APPL 11/2"X50YDS Catalog # GL-243
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 Pattern
US Nationwide distribution.
Code Information
GTIN: a. 809958001097. b. 809958001103. c. 00809958001127. d. 00809958001141. e. 00809958001165
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1799-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026