Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ Recalled by Biomedix, Inc. Due to Customer contacted Biomedix of complaint and returned the...

Date: August 14, 2014
Company: Biomedix, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Biomedix, Inc. directly.

Affected Products

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

Quantity: 2,928

Why Was This 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.

Where Was This Sold?

This product was distributed to 3 states: NC, OH, TX

Affected (3 states)Not affected

About Biomedix, Inc.

Biomedix, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report