The Recall Desk
HighFDA (Devices)·Z-0474-2016·Announced 2015-12-30

Becton Dickinson Recalls Enterococcus Screen Agar QUAD Plates

Becton Dickinson is recalling 770 units of Enterococcus Screen Agar QUAD Plates due to potential breakthrough growth of Enterococcus faecalis near the end of shelf life.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential breakthrough growth of a specific bacterial strain (Enterococcus faecalis) in a diagnostic medium, which poses a risk of inaccurate test results but does not involve reported illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Co. is recalling 770 units of Enterococcus Screen Agar QUAD Plates, catalog number 222201. The affected lots are 5064938, 5085954, 5105509, and 5133580. The product was distributed nationwide in the United States and internationally to Canada, Colombia, India, Mexico, and Europe.

The recall was initiated because the affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus faecalis ATCC 29212 near the end of shelf life. The source text notes that in-date product may also exhibit this breakthrough growth near the end of shelf life.

This is a Class II recall classified by the U.S. Food and Drug Administration. No specific instructions for consumers or healthcare providers are provided in the source text.

The recalled product

Product
Enterococcus Screen Agar QUAD Plate
Affected units
770

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • catalog number 222201. Lot numbers 5064938
  • 5085954
  • 5105509
  • and 5133580

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →