Home / Recalls / Steritec Products Mfc. Co., Inc. / Z-1826-2013

Z-1826-2013 Class II Terminated

Recalled by Steritec Products Mfc. Co., Inc. — Englewood, CO

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

Other recalls by Steritec Products Mfc. Co., Inc.

  • Z-1827-2013 Class II — Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, (June 10, 2013)
  • Z-1828-2013 Class II — Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Produ (June 10, 2013)
  • Z-1824-2013 Class II — EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTe (June 10, 2013)
  • Z-1829-2013 Class II — Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec (June 10, 2013)
  • Z-1822-2013 Class II — Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor P (June 10, 2013)
  • Z-1823-2013 Class II — Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor P (June 10, 2013)
  • Z-1825-2013 Class II — Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395 (June 10, 2013)