Recalls / —

—#177944

Product

Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A

FDA product code

CAI — Circuit, Breathing (W Connector, Adaptor, Y Piece)

Device class

Class 1

Medical specialty

Anesthesiology

Affected lot / code info

Product Model DYNJAPF6057A; Lots 19GBI659 and 19HBP065

Why it was recalled

The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end of the circuit.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Medline Industries Inc

Address

Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern

USA - 2 consignees in PA only

Timeline

Recall initiated

2019-10-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #177944. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.