Biomedix, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0023-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 14, 2014

Date Posted: October 15, 2014

Recall Number: Z-0023-2015

Event ID: 69249

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2,928

Code Information:

Model/Product Number: B30-102 Lot #416130 Exp. 12/2016

Distribution Pattern:

US Distribution including the states of OH, NC, and TX

Voluntary or Mandated:

Voluntary: Firm initiated