Device product
ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.
Z-1104-2017
Product summary
- Event
- Event 76101
- Status
- Terminated
- Classification
- Class II
- Quantity
- 328/ 50-count/ boxes; 16,400 individual units
- Official record key
device-enforcement:Z-1104-2017
Official wording
Reason: Product resistance has fallen outside of label claim within expiry.
Code information: Lot # 637, exp. date 12/2016
Distribution pattern: Product was distributed to: AL, AR, CA, FL, IA, MO, NE, NC, NY, OH, and WA. The product was also distributed internationally, including Mexico and Canada. There was no goverment or military distribution.
Derived failure modes
-
Unknown
Product resistance has fallen outside of label claim within expiry.