ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe

FDA device recall Z-1420-2023 · posted 2023-04-20 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.

Action taken

Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/20/2023 by USPS. The notice explained the issue and the hazard and requested the following actions be taken: Immediately locate, isolate, and cease all use of the affected product. The product code and lot number can be found on the product carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001, 7:00 am and 6:00 pm Central Time, Monday - Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. 4. If you purchased this product from a distributor, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, contact Baxter s Center for Service at 888-229-0001, between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KYX

Quantity affected

91,100 units

Distribution

US

Date initiated

2023-03-20

Date posted

2023-04-20

Location

Deerfield, IL