Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Reported: June 12, 2019 Initiated: July 13, 2018 #Z-1721-2019
Product Description
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Reason for Recall
Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
Details
- Recalling Firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- Units Affected
- 31904
- Distribution
- AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.
- Location
- Orange, CA
Frequently Asked Questions
What product was recalled? ▼
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution. Recalled by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical. Units affected: 31904.
Why was this product recalled? ▼
Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2019. Severity: Moderate. Recall number: Z-1721-2019.
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