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U.S. Department of Health and Human Services

Class 2 Device Recall Medline convenience kits

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  Class 2 Device Recall Medline convenience kits see related information
Date Initiated by Firm June 06, 2022
Create Date July 27, 2022
Recall Status1 Open3, Classified
Recall Number Z-1472-2022
Recall Event ID 90516
Product Classification Ear, nose, and throat surgical tray - Product Code OGR
Product Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927
Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
Code Information Lot Code: a. Model Number DYNJ0689093V, Lot Codes: 22DMI666, 21LBI103, 21HBO705, 21JBP781, 21JBQ762, 21FBG532, 21FBG535, b. Model Number DYNJ62927, Lot Numbers: 22BBB412
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - SPT
1170 S Northpoint Blvd
Waukegan IL 60085-6757
For Additional Information Contact Kassandra Cotner
866-775-6072
Manufacturer Reason
for Recall		 Kits contain leaking bottles of isopropyl alcohol
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations.
Quantity in Commerce 477 units
Distribution US Nationwide distribution.
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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