Devices

Device Recall Getinge Assure Accufast BI Test Pack w/ 25 Controls

Model / Serial
Affected Biological Indicator Lot No.:121101-447 and 121101-444
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
Product Description
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.
Manufacturer
Steritec Products Mfc. Co., Inc.
1 Event
- Recall of Device Recall Getinge Assure Accufast BI Test Pack w/ 25 Controls

Manufacturer

Steritec Products Mfc. Co., Inc.

Manufacturer Address
Steritec Products Mfc. Co., Inc., 74 Inverness Drive East, Englewood CO 80112-5114
Manufacturer Parent Company (2017)
Steritec Product Mfg. Co. Inc.
Source
USFDA

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