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U.S. Department of Health and Human Services

Class 2 Device Recall BioCORE Cannula

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  Class 2 Device Recall BioCORE Cannula see related information
Date Initiated by Firm January 23, 2015
Date Posted April 02, 2015
Recall Status1 Terminated 3 on August 06, 2015
Recall Number Z-1374-2015
Recall Event ID 70445
510(K)Number K141910  
Product Classification Cannula, injection - Product Code FGY
Product Bio-CORE Cannula (Needle) Set
Code Information Catalog Numbers: Part # BCORE.60, BCORE.80, and BCORE.105
Recalling Firm/
Manufacturer		 Biologic Therapies, Inc
5817 Nw 44th Ave
Ocala FL 34482-7891
For Additional Information Contact Zac Collins
352-304-5149
Manufacturer Reason
for Recall		 Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FGY and Original Applicant = BIOLOGIC THERAPIES INC
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