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U.S. Department of Health and Human Services

Class 2 Device Recall Central Line Dressing Change Tray

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 Class 2 Device Recall Central Line Dressing Change Traysee related information
Date Initiated by FirmAugust 12, 2020
Create DateSeptember 24, 2020
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-3013-2020
Recall Event ID 86341
Product Classification Dressing change tray - Product Code OXQ
ProductCentral Line Dressing Change Tray
Code Information Lot Number: 2020021990 Product Numbers: DYNDC1928C
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information ContactKassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		Potential of incomplete seals impacting the sterility of the kit.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn August 26th 2020 the firm sent an Urgent Recall letter to its consignees with the following information: This letter is to inform you that Medline Industries, Inc. is recalling our Central Line Dressing Change Tray DYNDC1928C and lot number 2020021990 due to the potential of incomplete seals impacting the sterility of the kit. REQUIRED ACTION: 1. Immediately check your stock for item number DYNDC1928C and the affected lot number, 2020021990. 2. Please destroy affected product, and complete the enclosed destruction form listing the quantity destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. Credit will be issued for recalled products, upon receipt of your completed destruction form. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. All affected product should be destroyed. If you have any questions, please contact 866-359-1704.
Quantity in Commerce60 kits
DistributionDomestic Distribution: MN and TX.
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.
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