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U.S. Department of Health and Human Services

Class 2 Device Recall Cardinal Health

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  Class 2 Device Recall Cardinal Health see related information
Date Initiated by Firm March 15, 2022
Create Date April 09, 2022
Recall Status1 Open3, Classified
Recall Number Z-0902-2022
Recall Event ID 89832
510(K)Number K110272  
Product Classification Surgeons gloves - Product Code KGO
Product Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Code Information Catalog Numbers: 1) 2D72PL65X, Lot Number TS21050195, EXP 04/30/2024 - UDI on ship case: 50885380031760; UDI on Dispenser carton: 20885380031769; UDI on individual unit: 10885380031762 2) 2D72PT65X, Lot Number TS21050215, EXP 04/30/2024 - UDI on ship case: 50885380031937, UDI on Dispenser carton: 20885380031936; UDI on individual unit: 10885380031939
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
Manufacturer Reason
for Recall		 Product was distributed without being sterilized.
FDA Determined
Cause 2		 Under Investigation by firm
Action A recall letter dated 03/16/2022 was distributed to impacted consignees. The letter informs consignees that a portion of the distributed lots were distributed without undergoing sterilization. Customers should review their inventory for the impacted lots, segregate and quarantine all affected product, complete the acknowledgement form and return to Cardinal Health. Any customers who may have received further distributed product should be contacted and provided the recall information.
Quantity in Commerce 486,578 pairs
Distribution Product distributed throughout United States and Guam
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KGO and Original Applicant = CARDINAL HEALTH, INC.
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