Getinge USA, Inc.
Rochester, NY, US
Getinge USA, Inc. appears in FDA device records in Rochester, NY. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Getinge USA, Inc. between 2003 and 2005. The busiest year on record is 2003, with 3. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 3 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K050664 | SPOR-TEST PA BIOLOGICAL INDICATOR KIT | FRC | Substantially Equivalent | |
| K032723 | BIOSIGN STEAM-24 BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | |
| K031647 | BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | JOJ | Substantially Equivalent | |
| K031259 | MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER | FLE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1994-2013 | 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 indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization. | 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. | Class II | Terminated | |
| Z-2079-2012 | Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128 | Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain