Recall Z-0050-2020— Baxter Healthcare Corporation
Class III · Terminated
Class III FDA medical device recall by Baxter Healthcare Corporation, initiated 2019-08-13, terminated 2020-11-23. FDA's recall record names no specific 510(k) clearance for this event. Product: EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent administration of liquid medication and nutrition to humans through the patient s mouth.. Reason: Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-08-13
- Terminated
- 2020-11-23
- Firm location
- Deerfield, IL, United States
Product description
EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent administration of liquid medication and nutrition to humans through the patient s mouth.
Reason for recall
Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.