CLASS II Device recall · Reported 7 Aug 2013 · FDA Enforcement Report
Cardinal BI Stat Biological Test Pack recalled
Steritec Products Mfc is recalling Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec, distributed nationwide in the US. The recall was initiated on 10 Jun 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1829-2013
- FDA event ID
- 65473
- Recalling firm
- Steritec Products Mfc, Englewood, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2013
- FDA classified
- 29 Jul 2013
- Reported
- 7 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 10 Jun 2013 | Recall initiated by company | |
| 29 Jul 2013 | Classified by FDA | +49 days |
| 7 Aug 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
Questions about this recall
Why was it 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.
Which lots are affected?
Affected Biological Indicator Lot No.:130401
Where was it sold?
Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 65473This product is part of a recall event; the main page for the event is Medline Steam Biological Indicators, SteriTec Product recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medline Steam Biological Indicators, SteriTec Product recalled | Steritec Products Mfc | Other | Nationwide | |
| CLASS II | Cardinal Steam Biological Indicator, SteriTec Product recalled | Steritec Products Mfc | Other | Nationwide | |
| CLASS II | Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product recalled | Steritec Products Mfc | Other | Nationwide | |
| CLASS II | Getinge Assure Accufast BI Test Pack w/ 25 Controls recalled | Steritec Products Mfc | Other | Nationwide | |
| CLASS II | EZTest Steam Biological Indicator, SteriTec Product recalled | Steritec Products Mfc | Other | Nationwide | |
| CLASS II | Medline Med-Checks BI Test packs recalled by Steritec Products Mfc. Co | Steritec Products Mfc | Other | Nationwide | |
| CLASS II | Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product recalled | Steritec Products Mfc | Other | Nationwide |
More recalls from Steritec Products Mfc
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product recalled | Steritec Products Mfc | Other | Nationwide |
| Device | CLASS II | Medline Med-Checks BI Test packs recalled by Steritec Products Mfc. Co | Steritec Products Mfc | Other | Nationwide |
| Device | CLASS II | EZTest Steam Biological Indicator, SteriTec Product recalled | Steritec Products Mfc | Other | Nationwide |
| Device | CLASS II | Getinge Assure Accufast BI Test Pack w/ 25 Controls recalled | Steritec Products Mfc | Other | Nationwide |
| Device | CLASS II | Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product recalled | Steritec Products Mfc | Other | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |