Z-1104-2017 Class II Terminated
FDA device recall Z-1104-2017 was initiated by Mesa Laboratories Inc on April 4, 2016 and is designated Class II. Reason for recall: Product resistance has fallen outside of label claim within expiry. The recall status is terminated (terminated January 26, 2017). Affected quantity: 328/ 50-count/ boxes; 16,400 individual units.
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2017
- Initiation Date
- April 4, 2016
- Termination Date
- January 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 328/ 50-count/ boxes; 16,400 individual units
Product Description
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.
Reason for Recall
Product resistance has fallen outside of label claim within expiry.
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.
Code Information
Lot # 637, exp. date 12/2016