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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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  Class 2 Device Recall Medline see related information
Date Initiated by Firm October 30, 2019
Create Date December 18, 2019
Recall Status1 Open3, Classified
Recall Number Z-0698-2020
Recall Event ID 84283
Product Classification Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
Product Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A
Code Information Product Model DYNJAPF6057A; Lots 19GBI659 and 19HBP065
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information Contact Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		 The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end of the circuit.
FDA Determined
Cause 2		 Under Investigation by firm
Action Consignees were notified via email by their sales representative on 11/05/2019. A letter with response form was sent via email to each consignee. Responses will be recorded and subsequent letters will be sent to those consignees that do not respond in the allotted time.
Quantity in Commerce 4040 units
Distribution USA - 2 consignees in PA only
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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