The Recall Desk
ModerateFDA (Devices)·Z-0473-2016·Announced 2015-12-30

Becton Dickinson Recalls Vancomycin Screen Agar Due to Growth Issues

Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because expired and in-date products may show breakthrough growth of vancomycin-susceptible Enterococcus faecalis near the end of shelf life.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard involves a performance defect (breakthrough growth) in a laboratory medium rather than a direct risk of serious injury or death to humans, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Becton Dickinson & Co. is recalling 60,840 units of Vancomycin Screen Agar, catalog number 222204. The recall covers specific lot numbers: 5041659, 5064921, 5076659, 5083712, 5097504, 5105955, 5130907, 5139626, and 5147941. The product was distributed nationwide in the United States and internationally to Canada, Colombia, India, Mexico, and Europe.

The recall was initiated because affected expired lots of the product may have exhibited breakthrough growth of vancomycin-susceptible Enterococcus faecalis ATCC 29212 near the end of the shelf life. The source text notes that in-date product may also exhibit this breakthrough growth near the end of the shelf life. This issue affects the performance of the laboratory medium rather than posing a direct physical hazard to users.

Users of this product should check their inventory for the specific catalog and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. This recall is classified as Class II by the FDA.

The recalled product

Product
Vancomycin Screen Agar
Affected units
60,840

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 (9)

  • catalog number 222204. Lot numbers 5041659
  • 5064921
  • 5076659
  • 5083712
  • 5097504
  • 5105955
  • 5130907
  • 5139626
  • and 5147941

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 →