Recall Z-1374-2015— Biologic Therapies, Inc

Name: FDA recall Z-1374-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-23

Class II · Terminated

Class II FDA medical device recall by Biologic Therapies, Inc, initiated 2015-01-23, terminated 2015-08-06. It names one FDA 510(k) clearance: K141910. Product: Bio-CORE Cannula (Needle) Set. Reason: Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution.

Recalling firm: Biologic Therapies, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-01-23
Terminated: 2015-08-06
Firm location: Ocala, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K141910 — Intraosseous Cannula System Bio-MAC¿ and Bio-COREBiologic Therapies, Inc.·cleared 2015-05-04

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

Bio-CORE Cannula (Needle) Set

Reason for recall

Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution

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