Recall Z-0023-2015— Biomedix, Inc.

Name: FDA recall Z-0023-2015
Creator: U.S. Food and Drug Administration
Published: 2014-08-14

Class II · Terminated

Class II FDA medical device recall by Biomedix, Inc., initiated 2014-08-14, terminated 2014-11-13. It names one FDA 510(k) clearance: K142097. 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. Reason: 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..

Recalling firm: Biomedix, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-08-14
Terminated: 2014-11-13
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K142097 — SELEC-3 I.V.ADMINISTRATION SETBiomedix, Inc.·cleared 2014-08-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.