Reported Jul 3, 2013 · Terminated

Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day…

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. · Route 120 And Wilson Rd · Round Lake, IL · 60073-9799

Is this the product you have?

  • Brand NameMultiday lnfusor, Seven
  • Day lnfusor and the Basal/Bolus lnfusorSingle day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h System, Two day Infusor 2 ml/h, Multiday Infusor 0.5 ml/h, Multiday INFUSOR 0.5ml/h System, Seven Day Infusor 0.5 ml/h, Seven Day INFUSOR 0.5ml/h System, Basal-Bolus Infusor-15min., Basal/Bolus INFUSOR 0.5 x 2 ml/h System with 15 Minute Lockout
  • Basal-Bolus Infusor Device ListingD018045 The Multiday lnfusor. Seven Day lnfusor and the BasaVBolus lnfusor are indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications
Lot codes and dates
  • Product Codes
    • 2C1071KJP
    • 2C1073KJP
    • 2C1075KJP
    • 2C1080KJP
    • 2C1082KJP
    • 2C1955KJP
    • 2C1976KJ
  • Expiration Dates
    • 06/30/13
    • 12/31/13
    • 06/30/14
    • 12/31/14
Amount recalled
601,230 total

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.

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 Jun 4, 2014 · Data as of Sep 19, 4:51 PM UTC

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