Reported Oct 15, 2014 · Terminated

Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging…

Biomedix, Inc.

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: Biomedix, Inc. · 3895 W Vernal Pike · Bloomington, IN · 47404-2533

Is this the product you have?

  • Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE
Lot codes and dates
  • Model/Product NumberB30-102 Lot #416130 Exp. 12/2016
Amount recalled
2,928

Where it was sold

Why it was recalled

Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure.

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 Nov 13, 2014 · Data as of Sep 19, 4:48 PM UTC

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