Recall Z-1824-2013 ยท FRC Indicator, Biological Sterilization Process
Steritec Products Mfc. Co., Inc.
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 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
| Date | Jul 29, 2013 (initiated Jun 10, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, SteriTec, sent all customers recall notifications via e-mail. The e-mail included a .pdf file of the recall notification letter entitled "URGENT: MEDICAL DEVICE RECALL" dated June 11, 2013. The letter described the product, problem and actions to be taken. The letter also informed customers of MesaLabs, "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to its customers. The customers were instructed to notify SteriTec products of receipt of this notification via email at: Jon@SteriTecproducts.com or fax to: 303-660-4213 Attn: Director Regulatory Affairs; examine the lot num |
| Quantity | 14,900 units |
| Distribution | Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930682 | EZTEST-STEAM Sgm Biotech, Inc., Apr 4, 1994 |