Home / Recalls / Medical Devices
Biomedix, Inc. recalls Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging in
Recalled October 15, 2014 · FDA recall Z-0023-2015 · Biomedix
Hazard
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. · FDA Class II
Units
2,928
Sold at
US Distribution including the states of OH, NC, and TX
Description
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.
Product
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
Manufacturer(s)
Biomedix, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →