FDA (Devices) recall action 65473

Steritec Products Mfc. Co., Inc. recalled 8 products on 2013-08-07

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2013-08-07
Critical: 0
Units: 57,665

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

ModerateFDA (Devices)··2013-08-07
SteriTec Steam Biological Test Packs Recalled for Labeling Inaccuracy
SteriTec is recalling 360 units of Steam Biological Test Packs because the readout time does not match the label claims.
Product
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
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0 states
ModerateFDA (Devices)··2013-08-07
SteriTec EZTest Steam Biological Indicator Recalled for Labeling Inaccuracy
SteriTec is recalling 200 units of EZTest Steam Biological Indicators because the readout time does not match the label claims.
Product
Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C a
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0 states
ModerateFDA (Devices)··2013-08-07
SteriTec Steam Biological Indicators Recalled for Labeling Inaccuracy
SteriTec is recalling EZTest Steam Biological Indicators because the readout time does not match the label claims.
Product
Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C
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0 states
ModerateFDA (Devices)··2013-08-07
SteriTec Biological Indicator Test Packs Recalled for Readout Time Issues
SteriTec is recalling specific lots of Getinge Assure Accufast BI Test Packs because the readout time does not match label claims.
Product
Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 a
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0 states
ModerateFDA (Devices)··2013-08-07
SteriTec EZTest Steam Biological Indicator Recall for Label Inaccuracy
SteriTec is recalling EZTest Steam Biological Indicators because the readout time does not match label claims.
Product
EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization
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0 states
ModerateFDA (Devices)··2013-08-07
SteriTec Steam Biological Test Packs Recalled for Labeling Inaccuracy
SteriTec is recalling specific steam biological test packs because the readout time does not match the label claims.
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 s
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0 states
ModerateFDA (Devices)··2013-08-07
SteriTec Recalls Smart-Read Biological Indicators Due to Readout Time Issues
SteriTec is recalling Smart-Read Biological Indicators because the readout time does not match label claims. The recall affects 5,000 units distributed worldwide.
Product
Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and
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0 states
ModerateFDA (Devices)··2013-08-07
SteriTec Biological Indicator Test Packs Recalled for Labeling Discrepancy
SteriTec is recalling specific lots of biological indicator test packs because the readout time does not match label claims.
Product
Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (2
Category
Distribution
0 states