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U.S. Department of Health and Human Services

Class 2 Device Recall Regimen 28 Day Glutaraldehyde Sterilizing and Disinfecting Solution

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 Class 2 Device Recall Regimen 28 Day Glutaraldehyde Sterilizing and Disinfecting Solutionsee related information
Date Initiated by FirmJuly 13, 2018
Date PostedJuly 05, 2019
Recall Status1 Terminated 3 on May 05, 2021
Recall NumberZ-1721-2019
Recall Event ID 82553
510(K)NumberK931052 
Product Classification Sterilant, medical devices - Product Code MED
ProductRegimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
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. 
FEI Number 2024312
Recalling Firm/
Manufacturer		 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information ContactCustomer Service
714-516-7400
Manufacturer Reason
for Recall		Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
FDA Determined
Cause 2		Error in labeling
ActionOn July 13, 2018, Metrex Research Corp., a subsidiary of Kerr Corporation, sent URGENT NOTICE: Regimen Glutaraldehyde letters to their consignees instructing them to check their inventory and complete the enclosed Field Action Acknowledement and Product Return Form. Distributors were requested to conduct sub-recalls to their consignees.
Quantity in Commerce31904
DistributionAZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.
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 = MED
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