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U.S. Department of Health and Human Services

Class 2 Device Recall Medline ENT Surgical Tray

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  Class 2 Device Recall Medline ENT Surgical Tray see related information
Date Initiated by Firm November 13, 2020
Create Date January 07, 2021
Recall Status1 Terminated 3 on October 26, 2021
Recall Number Z-0781-2021
Recall Event ID 86826
Product Classification Ear, nose, and throat surgical tray - Product Code OGR
Product Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Code Information Lot 20HBM370 (Expiration 02/28/2025); 20IBB678 (Expiration 03/31/2025); 20KBP338 (Expiration Date: 05/31/2025 never distributed)
Recalling Firm/
Manufacturer		 Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		 The cylindrical sponge component is not x-ray detectable.
FDA Determined
Cause 2		 Process control
Action Customers were notified by email on 11/13/2020. Customers are asked to return the response form via fax or email. The recalling firm will send subsequent letters to consignees that have not provided a response to the recall notification within the allotted time. No product is to be returned to Medline Industries. Consignees are instructed to apply labels to their affected kits and return to inventory. The label indicates that there is a recalled component within the pack, not to use it, and replace from a different sterile supply. No other components within the kit are affected.
Quantity in Commerce 40
Distribution Foreign distribution only - Canada.
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.
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