Recalls / —
—#174084
Product
EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
- FDA product code
- KYX — Dispenser, Liquid Medication
- Device class
- Class 1
- Medical specialty
- General Hospital
- Affected lot / code info
- REF H9388105, Lot Numbers: B301N017P, B301N070P, B302M338P, B304N045P REF H9388505, Lot Numbers: B301N023P, B301N049P, B302N077P REF H93884205, Lot Numbers: B301N056P, B302M333P, B303N042P, B307N015P
Why it was recalled
EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
The firm disseminated a safety alert to their consignees on 06/27/2019 by letter. The letter explained the 5mL syringes were commingled with 10mL syringes and directed the consignee separate the 5mL syringes from the 10mL syringes.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-06-27
- Terminated
- 2020-11-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #174084. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.