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U.S. Department of Health and Human Services

Class 2 Device Recall ChemoPlus Chemo Spill Kit Gowns

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  Class 2 Device Recall ChemoPlus Chemo Spill Kit Gowns see related information
Date Initiated by Firm January 07, 2021
Create Date February 05, 2021
Recall Status1 Terminated 3 on February 14, 2024
Recall Number Z-1082-2021
Recall Event ID 87145
510(K)Number K972615  
Product Classification Accessory, surgical apparel - Product Code LYU
Product Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
Code Information Lots: 916197X 916881X 919683X 920354X 924620X 928728X 931205X
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
Manufacturer Reason
for Recall		 Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
FDA Determined
Cause 2		 Process change control
Action URGENT MEDICAL DEVICE CORRECTION NOTICE notification letters dated 1/7/21 were sent to customers. Actions requested on your part: 1) REVIEW your inventory for affected product. 2) QUARANTINE affected product per Attachment 1 within your inventory 3) AFFIX one WARNING LABEL included with this notification to the front of each ChemoPlus" and ChemoBloc" Chemo Spill and Preparation/Administration kits so that it is clearly visible to clinicians, instructing them to remove the affected gown component prior to use. 4) COMMUNICATE this action with all personnel the need to remove the gowns prior to use. 5) NOTIFY any customers to whom you may have distributed or forwarded affected product about this product action. 6) RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to gmb-fieldcorrectiveaction@cardinalhealth.com, whether or not you have affected product. Please contact the Customer Service group for any questions or to arrange for credit and return of any product: " Hospital800-964-5227 " Federal Government800-444-1166 " Distributor800-635-6021 " All other customers888-444-5440 For questions related to the notification, additional warning labels requests and/or acknowledgement form, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
Quantity in Commerce 137,346 kits
Distribution Global Distribution. US Nationwide.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LYU and Original Applicant = WEMBLEY RUBBER PRODUCTS (M) SDN BHD
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