Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0698-2020Class II

Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A

MEDLINE INDUSTRIES, LP - Northfield / initiated 2019-10-30 / Open, Classified

Medline Industries Inc began a recall of Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A on . FDA classified it as Class II and gives the reason as "The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end of the circuit". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-0698-2020
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A
Product code
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Reason for recall
The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end of the circuit.
FDA root cause
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
Product codes and lots
Product Model DYNJAPF6057A; Lots 19GBI659 and 19HBP065

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0698-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0698-2020Class IIOngoingVoluntary: Firm initiated