FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
- Recall number
- Z-2432-2019
- Recalling firm
- Baxter Healthcare Corporation
- Product
- EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
- Status
- Terminated
- Initiated
- 2019-06-27
- Posted
- not on file
- Terminated
- 2020-11-02
- Reason
- EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 2192000 syringes
- Distribution
- Nationwide
- Lot, serial or model codes
- REF H9388105, Lot Numbers: B301N017P, B301N070P, B302M338P, B304N045P REF H9388505, Lot Numbers: B301N023P, B301N049P, B302N077P REF H93884205, Lot Numbers: B301N056P, B302M333P, B303N042P, B307N015P
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYX
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28