Acumedia Manufacturers, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2221-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production

Product Classification:

Class III

Date Initiated: September 25, 2016

Date Posted: June 14, 2017

Recall Number: Z-2221-2017

Event ID: 77276

Reason for Recall:

Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.

Status: Terminated

Product Quantity: 28 units

Code Information:

PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C

Distribution Pattern:

Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL

Voluntary or Mandated:

Voluntary: Firm initiated