Z-1374-2015Class II

Bio-CORE Cannula (Needle) Set

Name: Z-1374-2015 Bio-CORE Cannula (Needle) Set
Creator: Biologic Therapies, Inc
Published: 2015-01-23
License: https://open.fda.gov/license/

Biologic Therapies, Inc. / initiated 2015-01-23 / Terminated / root cause: labeling and UDI

FDA source

Biologic Therapies, Inc began a recall of Bio-CORE Cannula (Needle) Set on 2015-01-23. FDA classified it as Class II and gives the reason as "Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1374-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-23
Posted: 2015-04-02
Terminated: 2015-08-06
Recalling firm: Biologic Therapies, Inc.
Product: Bio-CORE Cannula (Needle) Set
Product code: FGY Cannula, Injection
Reason for recall: Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Root cause tag: labeling and UDI
FDA root cause: Use error
Action: On January 23, 2015 the firm sent an URGENT: Class II MEDICAL DEVICE RECALL notification asking its consignees to: 1) Quarantine all remaining devices in their inventory and return the product to Biologic Therapies Inc. via UPS Ground. Product returns should be shipped under UPS Account #A197E9 and must reference RMA#15-0115-01. Please ship to the Biologic Therapies Inc. address listed at the bottom of Page 5. To coordinate return shipping, please contact Biologic Therapies, Inc. via the contact information provided.Contact hours: Monday - Friday 8am to 5pm Eastern Standard Time. (352) 304-5149 2) Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 0 (distributed or released)
Distribution: US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
Product codes and lots: Catalog Numbers: Part # BCORE.60, BCORE.80, and BCORE.105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1374-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1372-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-02
Z-1373-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-02
Z-1374-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-02

Product code FGY

K141910Class IIIntraosseous Cannula System Bio-MAC¿ and Bio-COREBiologic Therapies, Inc. / cleared 2015-05-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)