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
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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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