Reported Jan 8, 2014 · Terminated

IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing…

Baxter Healthcare Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • 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.
Lot codes and dates
    • 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
Amount recalled
28 devices

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 23, 2015 · Data as of Sep 19, 6:06 PM UTC

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