Recall Z-2614-2021

ConvaTec, Inc · initiated August 20, 2021

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)

Codes / lots: Lot Number 8G03458, Expiry Jul 2023

Reason for recall

Primary packaging labeling may be incorrect.

FDA-determined cause: Environmental control

Action taken

Consignees are notified of the recall via email and letter delivered via UPS. The recalling firm identifies Tier 1 customers as direct consignees and Tier 2 customers and those who receive product from Tier 1 customers. Impacted customers that identify affected product within their inventory are to arrange for return of product through third party Sedgwick.

Details

Recall number
Z-2614-2021
Initiated
August 20, 2021
Product code
NAD – Dressing, Wound, Occlusive
Quantity
170 packs
Distribution
Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA
Recalling firm
ConvaTec, Inc, Greensboro, NC

Official FDA recall record