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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0698-2020 | Class II | Ongoing | Voluntary: Firm initiated |
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