FDA recall Z-0806-2018

Product

Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

Reason for recall

Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).

Distribution

Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.

Key facts

Status

Terminated

Initiation date

2018-02-06

Report date

2018-03-07

Termination date

2021-04-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0806-2018