—#175678

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.

FDA product code: N/A
Affected lot / code info: (a) REF H9388105, Lot Numbers: B301N017P, B301N070P, B304N045P (b) REF H9388505, Lot Numbers: B301N023P, B301N049P, B302N077P, B303N108P (c) REF H93884205, Lot Numbers: B301N056P, B303N042P, B307N015P

Why it was recalled

Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm issued a safety alert on 08/13/2019 by letter. The letter explained the 5mL syringes were commingled with 3mL syringes and directed the consignee separate the 5mL syringes from the 3mL syringes.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide distribution - including US Nationwide distribution, and country of Canada.

Timeline

Recall initiated: 2019-08-13
Posted by FDA: 2019-10-07
Terminated: 2020-11-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175678. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.