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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE NONSTERILE PVP SOLUTION

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 Class 2 Device Recall MEDLINE NONSTERILE PVP SOLUTIONsee related information
Date Initiated by FirmMay 18, 2023
Date PostedJuly 12, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2135-2023
Recall Event ID 92486
Product Classification General surgery tray - Product Code LRO
ProductMEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Code Information UDI/DI (EA) (01)10193489799477, UDI/DI (01)40193489799478; Lot Numbers: 23CBS268
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
886-359-1704
Manufacturer Reason
for Recall		Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
FDA Determined
Cause 2		Process control
ActionMedline issued a recall notice on 06/02/2023 to its consignees via USPS first class mail. The notice explained the problem with the product and requested the destruction of the product. Medline identified additional products, lots, and consignees and notified their consignees by email on 06/09/2023. Upon receipt of the submitted response form each account will receive over-labels to affix to the affected kits via FedEx overnight, if applicable. distributors were directed to notify their customers and collect the returned product and return it to Medline.
Quantity in Commerce60 units
DistributionWorldwide distribution - US Nationwide and the country of Panama.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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