FDA Device recall Z-1104-2017
ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, conta…
- FDA Device
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, conta… by Mesa Laboratories, citing product resistance has fallen outside of label claim within expiry.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1104-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-04 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mesa Laboratories |
| Distribution | AL, AR, CA, FL, IA, MO, NC, NE, NY, OH, WA |
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.
Reason
Product resistance has fallen outside of label claim within expiry.
Identifiers
| code_info | Lot # 637, exp. date 12/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1104-2017%22
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