ClearanceBrief
Recall Z-0698-2020 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

Medline Industries Inc

Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A

DateOct 30, 2019
StatusOpen, Classified
ReasonThe 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end of the circuit.
Root causeUnder Investigation by firm
ActionConsignees 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.
Quantity4040 units
DistributionUSA - 2 consignees in PA only
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.