Z-1104-2017Class II

ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus...

Name: Z-1104-2017 ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus...
Creator: Mesa Laboratories Inc
Published: 2016-04-04
License: https://open.fda.gov/license/

Mesa Laboratories Inc / initiated 2016-04-04 / Terminated / root cause: manufacturing process

FDA source

Mesa Laboratories Inc began a recall of ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box... on 2016-04-04. FDA classified it as Class II and gives the reason as "Product resistance has fallen outside of label claim within expiry". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1104-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Posted: 2017-01-26
Terminated: 2017-01-26
Recalling firm: Mesa Laboratories Inc
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.
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: Product resistance has fallen outside of label claim within expiry.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: MesaLabs 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 [email protected] or call at 303-987-8000 ext. 10042.
Quantity in commerce: 328/ 50-count/ boxes; 16,400 individual units
Distribution: 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.
Product codes and lots: Lot # 637, exp. date 12/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1104-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1104-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-26

Product code FRC

K971432Class IIProsporeRaven Biological Laboratories, Inc. / cleared 1997-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)