FDA recall Z-1798-2022

Mckesson Medical-Surgical Inc. Corporate Office · Class III · device

Product

a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog #68751510104. b. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR BARR 10X12 (5/BX) Catalog #68751510105

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.

Key facts

Status: Ongoing
Initiation date: 2022-05-25
Report date: 2022-10-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1798-2022