Z-1826-2013 Class II Terminated
FDA device recall Z-1826-2013 was initiated by Steritec Products Mfc. Co., Inc. on June 10, 2013 and is designated Class II. 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 specif… The recall status is terminated (terminated December 19, 2013). Affected quantity: 15,300 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2013
- Initiation Date
- June 10, 2013
- Termination Date
- December 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,300 units
Product Description
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 (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.
Code Information
Affected Biological Indicator Lot No.:121101-447 and 121101-444