FDA recall D-0299-2018

Medline Industries Inc · Class II · drug

Product

Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Distribution

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

Key facts

Status
Terminated
Initiation date
2017-09-21
Report date
2018-02-07
Termination date
2023-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0299-2018