CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report
Bio-CORE Cannula (Needle) Set recalled by Biologic Therapies
Biologic Therapies is recalling Bio-CORE Cannula (Needle) Set, distributed in 7 states. The recall was initiated on 23 Jan 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1374-2015
- FDA event ID
- 70445
- Recalling firm
- Biologic Therapies, Ocala, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jan 2015
- FDA classified
- 2 Apr 2015
- Reported
- 8 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 23 Jan 2015 | Recall initiated by company | |
| 2 Apr 2015 | Classified by FDA | +69 days |
| 8 Apr 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Product as listed by the FDA
Bio-CORE Cannula (Needle) Set
Where it was distributed
US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
CaliforniaFloridaIllinoisMassachusettsNew JerseyTexasWashington
Questions about this recall
Why was it recalled?
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Which lots are affected?
Catalog Numbers: Part # BCORE.60, BCORE.80, and BCORE.105
Where was it sold?
US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 70445| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bio-Plasty Cannula (Needle) recalled by Biologic Therapies | Biologic Therapies | Labeling Errors | 7 states | |
| CLASS II | Bio-MAC Cannula (Needle) Set recalled by Biologic Therapies | Biologic Therapies | Labeling Errors | 7 states |
More recalls from Biologic Therapies
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Bio-MAC Cannula (Needle) Set recalled by Biologic Therapies | Biologic Therapies | Labeling Errors | 7 states |
| Device | CLASS II | Bio-Plasty Cannula (Needle) recalled by Biologic Therapies | Biologic Therapies | Labeling Errors | 7 states |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |