EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (
FDA device recall Z-0050-2020 · posted 2019-10-07 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- N/A
- Quantity affected
- 2,719,200 dispenser units
- Distribution
- Worldwide distribution - including US Nationwide distribution, and country of Canada.
- Date initiated
- 2019-08-13
- Date posted
- 2019-10-07
- Date terminated
- 2020-11-23
- Location
- Deerfield, IL
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