Steritec Products Mfc. Co., Inc.: Medical Device Recall in 2013 - (Recall #: Z-1829-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.

Product Classification:

Class II

Date Initiated: June 10, 2013

Date Posted: August 7, 2013

Recall Number: Z-1829-2013

Event ID: 65473

Reason for Recall:

Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.

Status: Terminated

Product Quantity: 360 units

Code Information:

Affected Biological Indicator Lot No.:130401

Distribution Pattern:

Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated