CLASS II Device recall · Reported 3 Feb 2021 · FDA Enforcement Report

Brain Heart Infusion Agar with 6 ug/ml Vancomycin recalled

Hardy Diagnostics is recalling Brain Heart Infusion Agar with 6 ug/ml Vancomycin, distributed in 11 states. The recall was initiated on 21 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698

Quantity recalled820 units (82 PK10)

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-0919-2021
FDA event ID: 87091
Recalling firm: Hardy Diagnostics, Santa Maria, CA
Classification: Class II
Status: Terminated
Recall initiated: 21 Dec 2020
FDA classified: 25 Jan 2021
Reported: 3 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Bacterial Contamination
Device type: Other Medical Devices

Timeline

21 Dec 2020	Recall initiated by company
25 Jan 2021	Classified by FDA	+35 days
3 Feb 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.

Product as listed by the FDA

Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml

Where it was distributed

U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None

Arizona California Connecticut Georgia Indiana Massachusetts Michigan Puerto Rico Tennessee Utah Washington

Questions about this recall

Why was it recalled?

Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.

Which lots are affected?

Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698

Where was it sold?

U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None

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.

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