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Terminated

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

FDA Recall Z-0806-2018 · Posted None

Recall StatusTerminated
Product CodeKYZ
Date Initiated2018-02-06
Date Terminated2021-04-02
Product Quantity2,800 units

Reason for Recall

Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).

Firm Action

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.

Root Cause

Employee error

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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