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Terminated

Bio-CORE Cannula (Needle) Set

FDA Recall Z-1374-2015 · Posted 2015-04-02

Recalling FirmBiologic Therapies, Inc
Recall StatusTerminated
Product CodeFGY
Date Initiated2015-01-23
Date Terminated2015-08-06
Product Quantity0 (distributed or released)

Reason for Recall

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

Firm 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.

Root Cause

Use error

Distribution Pattern

US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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