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Recall Observatory FDA recall evidence

Device product

Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

Z-1721-2019

July 13, 2018

Class II

Product summary

Firm
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Event
Event 82553
Status
Terminated
Classification
Class II
Quantity
31904
Official record key
device-enforcement:Z-1721-2019

Official wording

Reason: Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.

Code information: Part Number: 10-6465 (McKesson Reorder # 341) Lot Numbers: 16 1250, 16 1274, 16 1324A, 16 1324B, 16 2337, 17 1038, 17 1038A, 17 1083, 17 1193, 17 1262, 17 2122, 17 2142, 17 2219, 17 2306, 17 2347A, 18 1092B, 18 1121, 18 2037, and 18 3164.

Distribution pattern: AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.