FDA Device recall Z-0607-2014
IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its fo…
- FDA Device
- Class II
- terminated
- Published 2014-01-08
On 2014-01-08 the FDA classified a Class II recall of IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its fo… by Baxter Healthcare, citing following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the po….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0607-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-08 |
| Published | 2014-01-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.
Reason
Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill syringes with the HEPA filtration disabled.
Identifiers
| code_info | Lot # 123, 125R, 127, 129, 145, 146R, 147R, 148, 215R, 500, 501, 502, 503, 504, 505, 506, 508, 510, 511R, 512, 514, 515, 516R, 517, 518, 519, and 520. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0607-2014%22
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