OFFICIAL-SOURCE RECALL · AUSTRALIA
Steam Sterilizers with vertical moving doors Recall: Classification Class II Reason for the Action
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Steam Sterilizers with vertical moving doors
- Manufacturer
- See official notice
- Lot number
- numbers
- Batch number
- numbers
- Model number
- Numbers
- Serial number / range
- Numbers
- Date code
- dates
- Expiration date
- dates
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
Classification Class II Reason for the Action Getinge Sterilization AB received a report of a user injury involving the autoclave door. The sterilisation technician activated the door lock while a basket was obstructing the door’s movement. Rather than reopening the door and repositioning the basket, the technician attempted to manually adjust the basket while the door was closing. When the basket became dislodged, the door closed and resulted in a serious crushing injury to the technician’s hand. During further investigation, a second complaint involving a similar device was also identified. Instructions for Customers/Users Customers are to: 1. Continue operating the affected sterilisers in accordance with the Instructions for Use and all safety precautions described in the User Manual. 2. Ensure that all relevant personnel are informed of and adhere to the following safety measures: o The emergency stop button must be used prior to attempting to reposition any load or obstruction that may interfere with door movement. o Personnel must not reach into the chamber when the door is stuck, obstructed, or in motion. 3. Complete the Customer Response Form and return it to Quality.AUNZ@g
Hazard
Classification Class II Reason for the Action Getinge Sterilization AB received a report of a user injury involving the autoclave door. The sterilisation technician activated the door lock while a basket was obstructing the door’s movement. Rather than reopening the door and repositioning the basket, the technician attempted to manually adjust the basket while the door was closing. When the basket became dislodged, the door closed and resulted in a serious crushing injury to the technician’s hand. During further investigation, a second complaint involving a similar device was also identified. Instructions for Customers/Users Customers are to: 1. Continue operating the affected sterilisers in accordance with the Instructions for Use and all safety precautions described in the User Manual. 2. Ensure that all relevant personnel are informed of and adhere to the following safety measures: o The emergency stop button must be used prior to attempting to reposition any load or obstruction that may interfere with door movement. o Personnel must not reach into the chamber when the door is stuck, obstructed, or in motion. 3. Complete the Customer Response Form and return it to Quality.AUNZ@g
Official recall notice
Steam Sterilizers with vertical moving doors
Agency: Therapeutic Goods Administration
Official publication date: September 4, 2019
Read the official AU_TGA_DRAC recall notice →Scan products you own
Scan products you own once and let RecallGuard monitor future official recalls.
Scan & Monitor Products