PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 7, 2018 Initiated: February 6, 2018 #Z-0806-2018

Product Description

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).

Details

Units Affected
2,800 units
Distribution
Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105. Recalled by Baxter Healthcare Corporation. Units affected: 2,800 units.
Why was this product recalled?
Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
Which agency issued this recall?
This recall was issued by the FDA Devices on March 7, 2018. Severity: Moderate. Recall number: Z-0806-2018.