FDA-Device2014-10-15Class II
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
Biomedix, Inc.
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.
Sold states
US Distribution including the states of OH, NC, and TX
Affected count
2,928
Manufactured in
3895 W Vernal Pike, Bloomington, IN, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0023-2015Don't want to check this manually?
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