Bio-CORE Cannula (Needle) Set
FDA device recall Z-1374-2015 · posted 2015-04-02 · Terminated
Recall details
- Recalling firm
- Biologic Therapies, Inc
- Reason for recall
- Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
- Action taken
- 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
- Status
- Terminated
- Product code
- FGY
- Quantity affected
- 0 (distributed or released)
- Distribution
- US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
- Date initiated
- 2015-01-23
- Date posted
- 2015-04-02
- Date terminated
- 2015-08-06
- Location
- Ocala, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Intraosseous Cannula System Bio-MAC¿ and Bio-CORE (K141910) | Biologic Therapies, Inc. | 2015-05-04 |