Recall Z-0806-2018— Baxter Healthcare Corporation

Name: FDA recall Z-0806-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-06

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2018-02-06, terminated 2021-04-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105. Reason: Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL)..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-02-06
Terminated: 2021-04-02
Firm location: Deerfield, IL, United States

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.