Sterile EXACTAMED Oral Dispenser recall: Labeling Error
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Why was Sterile EXACTAMED Oral Dispenser 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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot No. 1203395, Expiration Date 11/30/2019
- Product
- Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 2,800 units
- Distribution
- Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.
- Recall date
- March 7, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)