CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report

Bio-MAC Cannula (Needle) Set recalled by Biologic Therapies

Biologic Therapies is recalling Bio-MAC 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

Lot, batch or date codesCatalog Numbers: Part # BMAC.25, BMAC.45, BMAC.60, BMAC.80, and BMAC.105

Quantity recalled2797 units

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-1373-2015
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-MAC Cannula (Needle) Set

Where it was distributed

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

California Florida Illinois Massachusetts New Jersey Texas Washington

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 # BMAC.25, BMAC.45, BMAC.60, BMAC.80, and BMAC.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

This product is part of a recall event; the main page for the event is Bio-CORE Cannula (Needle) Set recalled by Biologic Therapies.

Reported	Class	Recall	Company	Reason	Where
8 Apr 2015	CLASS II	Bio-CORE Cannula (Needle) Set recalled by Biologic Therapies	Biologic Therapies	Labeling Errors	7 states
8 Apr 2015	CLASS II	Bio-Plasty Cannula (Needle) recalled by Biologic Therapies	Biologic Therapies	Labeling Errors	7 states

More recalls from Biologic Therapies

All 3

Reported	Class	Recall	Company	Reason	Where
8 Apr 2015Device	CLASS II	Bio-Plasty Cannula (Needle) recalled by Biologic Therapies	Biologic Therapies	Labeling Errors	7 states
8 Apr 2015Device	CLASS II	Bio-CORE Cannula (Needle) Set recalled by Biologic Therapies	Biologic Therapies	Labeling Errors	7 states

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All 6,199

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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide