FDA recall D-1360-2014

Carefusion 2200 Inc · Class II · drug

Product

CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15.

Reason for recall

Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.

Distribution

Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines

Key facts

Status
Terminated
Initiation date
2013-12-20
Report date
2014-06-11
Termination date
2015-06-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Vernon Hills, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1360-2014