Recall Z-1828-2013— Steritec Products Mfc. Co., Inc.

Name: FDA recall Z-1828-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-10

Class II · Terminated

Class II FDA medical device recall by Steritec Products Mfc. Co., Inc., initiated 2013-06-10, terminated 2013-12-19. It names one FDA 510(k) clearance: K001444. Product: Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR 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. Reason: 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..

Recalling firm: Steritec Products Mfc. Co., Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-10
Terminated: 2013-12-19
Firm location: Englewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K001444 — STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103Steritec Products, Inc.·cleared 2000-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR 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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.