Recall Z-1826-2013 ยท FRC Indicator, Biological Sterilization Process
Steritec Products Mfc. Co., Inc.
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.
| 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 | 15,300 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
| K111150 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR Steritec Products Mfg Co, Inc., Jul 8, 2011 |