FDA Medical Device Recalls (openFDA)
Biologic Therapies, Inc: Bio-PLASTY Cannula (Needle)
- Recall number
- Z-1372-2015
- Recalling firm
- Biologic Therapies, Inc
- Product
- Bio-PLASTY Cannula (Needle)
- Status
- Terminated
- Initiated
- 2015-01-23
- Posted
- 2015-04-02
- Terminated
- 2015-08-06
- Reason
- Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
- 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
- 58
- Distribution
- US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
- Lot, serial or model codes
- Catalog Numbers: Part # BPC.45, BPC.60, BPC.80, and BPC.105
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FGY
- Firm FEI
- 3009790112
- Firm city
- Ocala
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28