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U.S. Department of Health and Human Services

Class 2 Device Recall UNIVERSAL CORE DR RUNNELS PACK

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  Class 2 Device Recall UNIVERSAL CORE DR RUNNELS PACK see related information
Date Initiated by Firm November 17, 2022
Date Posted February 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-1064-2023
Recall Event ID 91386
Product Classification Myringotomy procedure kit - Product Code OGS
Product UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
Code Information Item Number: DYNJ52230, Case UDI/GTIN: 40889942252269, Unit UDI/GTIN: 10889942252268, Lot Number: 22IBJ862
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer Reason
for Recall		 Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
FDA Determined
Cause 2		 Device Design
Action Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
Quantity in Commerce 20 cases (120 units)
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
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.
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