Recall Z-1994-2013 ยท FRC Indicator, Biological Sterilization Process
Getinge USA Inc
Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121C, 132C, 134C and 135C steam sterilization cycles. The AccuFast BI is a self-contained biological ind
| Date | Aug 21, 2013 (initiated Aug 2, 2013) |
| Status | Terminated |
| Reason | AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters. |
| Root cause | Other |
| Action | GETINGE sent an DEVICE CORRECTION NOTICE letter dated July 31, 2013, and response forms were sent to customers on August 2, 2013, via Certified Mail Return Receipt Requested. The letters instruct customers to immediately discontinue use, quarantine, and destroy the affected lot. In addition, they instruct customers to: Check the appropriate box and record the quantity of affected unused product on the enclosed Correction Response Form OR If if they do not have any lots of affected unused inventory check the box indicating such. Destroy the unused product in accordance with your institutio |
| Quantity | Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs) |
| Distribution | Worldwide Distribution - USA and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093794 | SMART-READ EZTEST-STEAM SCBI AND TEST PACK Sgm Biotech, Inc., May 14, 2010 |