Z-1623-2022 Class II Ongoing
FDA device recall Z-1623-2022 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on May 25, 2022 and is designated Class II. 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. 772 b. 9 c. 1 d. 1.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2022
- Initiation Date
- May 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a. 772 b. 9 c. 1 d. 1
Product Description
a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST Catalog # GL103. d. DERMA SCIENCES, INC. Surgitube & Surgigrip APPLICATOR, SURGITUBE/GRIP METAL SZ3 6" CHLD/ADLT DERSCI Catalog #GL-234.
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.
Distribution Pattern
US Nationwide
Code Information
a. GTIN: 00753567101252; 10753567101259. b. GTIN: 809958001158. c. GTIN: Not Available. d. GTIN: unknown
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1623-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026