Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Pro...

FDA Device Recall #Z-1825-2013 — Class II — June 10, 2013

Recall Summary

Recall Number Z-1825-2013
Classification Class II — Moderate risk
Date Initiated June 10, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Steritec Products Mfc. Co., Inc.
Location Englewood, CO
Product Type Devices
Quantity 10,170 units

Product Description

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 and 3 minutes at 135 pre-vacuum steam sterilizers.

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.

Distribution Pattern

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

Lot / Code Information

Affected Biological Indicator Lot No.:121101-447 and 121101-444

Other Recalls from Steritec Products Mfc. Co., Inc.

Recall # Classification Product Date
Z-1822-2013 Class II Medline Steam Biological Indicators, SteriTec P... Jun 10, 2013
Z-1823-2013 Class II Cardinal Steam Biological Indicator, SteriTec P... Jun 10, 2013
Z-1827-2013 Class II Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack,... Jun 10, 2013
Z-1826-2013 Class II Getinge Assure Accufast BI Test Pack w/ 25 Cont... Jun 10, 2013
Z-1829-2013 Class II Cardinal BI Stat Biological Test Pack with Inst... Jun 10, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.