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U.S. Department of Health and Human Services

Class 2 Device Recall ProSpore 4 mL

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 Class 2 Device Recall ProSpore 4 mLsee related information
Date Initiated by FirmApril 04, 2016
Create DateJanuary 26, 2017
Recall Status1 Terminated 3 on January 26, 2017
Recall NumberZ-1104-2017
Recall Event ID 76101
510(K)NumberK971432 
Product Classification Indicator, biological sterilization process - Product Code FRC
ProductProSpore 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.
Code Information Lot # 637, exp. date 12/2016
Recalling Firm/
Manufacturer		 Mesa Laboratories Inc
PO Box 27261
8607 Park Dr
Omaha NE 68127-3623
For Additional Information ContactJanis E. Smoke
303-987-8000 Ext. 10352
Manufacturer Reason
for Recall		Product resistance has fallen outside of label claim within expiry.
FDA Determined
Cause 2		Process control
ActionMesaLabs sent an Urgent Notification letter dated April 4. 2016 to customers. Follow-up emails were sent to verify receipt. The letter identified the affected product, problem and actions to be taken. For questions contact MesaLabs technical support team via email at bi-support@mesalabs.com or call at 303-987-8000 ext. 10042.
Quantity in Commerce328/ 50-count/ boxes; 16,400 individual units
DistributionProduct 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRC
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