RecallRadar

FDA Device recall Z-0806-2018

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

On 2018-03-07 the FDA classified a Class II recall of Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105 by Baxter Healthcare, citing affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0806-2018
ClassificationClass II
Statusterminated
Initiated2018-02-06
Published2018-03-07
Last updated2026-09-13 11:54 UTC
CompanyBaxter Healthcare
DistributionIL, MA, MD, OH, SD, TX, VA, WI

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).

Identifiers

code_infoLot No. 1203395, Expiration Date 11/30/2019

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0806-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.