Recalls / —

—#161319

Product

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

FDA product code

KYZ — Syringe, Irrigating (Non Dental)

Device class

Class 1

Medical specialty

General Hospital

Affected lot / code info

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

Why it was 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).

Root cause (FDA determination)

Employee error

Action the firm took

Customers were notified via letter on about 02/06/2018. Instructions include to locate and remove affected product in inventory, confirm mislabeled 5 mL oral dispensers (Lot number 1203395) in the individual pouch are not mixed together with 1 mL oral dispensers (Product code H93876101) or other stored product, contact Baxter Healthcare Center to arrange return of affected product, and complete and return the customer reply form if purchased directly from Baxter. Also, customer are instructed to notify customers and conduct a consumer-level recall if the affected product was further distributed. Questions and concerns can be directed to the Public Contact, Center for One Baxter with phone number (Toll Free) 800-422-9837 and 847-948-4770, Monday through Friday 8:00 AM to 5:00 PM CST.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.

Timeline

Recall initiated

2018-02-06

Terminated

2021-04-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #161319. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.