CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report
Cocoon Convective Warming System, Product recalled
Care Essentials Pty is recalling Cocoon Convective Warming System, Product, distributed nationwide in the US. The recall was initiated on 7 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0986-2020
- FDA event ID
- 84541
- Recalling firm
- Care Essentials Pty, North Geelong, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jan 2020
- FDA classified
- 4 Feb 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Jan 2020 | Recall initiated by company | |
| 4 Feb 2020 | Classified by FDA | +28 days |
| 12 Feb 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.
Product as listed by the FDA
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
Where it was distributed
US Nationwide in the states of AZ CA FL GA KS LA MA MD MI MN NC NM NY OH PA QC SC TX VA WV and the Foreign distribution to Canada.
Nationwide ArizonaCaliforniaFloridaGeorgiaKansasLouisianaMassachusettsMarylandMichiganMinnesotaNorth CarolinaNew MexicoNew YorkPennsylvaniaSouth CarolinaTexasVirginiaWest Virginia
Questions about this recall
Is Cocoon Convective Warming System, Product recalled?
Yes. Care Essentials Pty recalled Cocoon Convective Warming System, Product on 7 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-0986-2020.
Why was it recalled?
Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.
Which lots are affected?
Product Code: CWS4000 (110V) Serial Numbers: CWS4-10001-14, CWS4-10002-14, CWS4-10003-14, CWS4-10004-14, CWS4-10005-14, CWS4-10006-14, CWS4-10007-14, CWS4-10008-14, CWS4-10009-14, CWS4-10010-14, CWS4-10011-14, CWS4-10012-14, CWS4-10013-14, CWS4-10014-14, CWS4-10015-14, CWS4-10016-14, CWS4-10017-14, CWS4-10018-14, CWS4-10020-14, CWS4-10021-14, CWS4-10022-14, CWS4-10023-14, CWS4-10024-14, CWS4-10025-14, CWS4-10026-14, CWS4-10027-14, CWS4-10028-14, CWS4-10029-14, CWS4-10030-14, CWS4-10031-14, CWS4-10032-14, CWS4-10033-14, CWS4-10035-14, CWS4-10036-14, CWS4-10037-14, CWS4-10038-14, CWS4-10039-14, CWS4-10040-14, CWS4-10041-14, CWS4-10042-14, CWS4-10043-14, CWS4-10044-14, CWS4-10045-14, CWS4-10046-14, CWS4-10047-14, CWS4-10049-14, CWS4-10050-14, CWS4-10051-14, CWS4-10052-14, CWS4-10053-14, CWS4-10054-14, CWS4-10055-14, CWS4-10056-14, CWS4-10057-14, CWS4-10058-14, CWS4-10059-14, CWS4-10060-14, CWS4-10061-14, CWS4-10062-14, CWS4-10063-14, CWS4-10064-14, CWS4-10065-14, CWS4-10066-14, CWS4-10067-14, CWS4-10068-14, CWS4-10069-14, CWS4-10070-14, CWS4-10071-14, CWS4-10072-14, CWS4-10073-14, CWS4-10074-14, CWS4-10075-14, CWS4-10076-14, CWS4-10077-14, CWS4-10078-14, CWS4-10079-14, CWS4-10080-14, CWS4-10081-14, CWS4-10082-14, CWS4-10083-14, CWS4-10084-14, CWS4-10085-14, CWS4-10086-14, CWS4-10087-14, CWS4-10088-14, CWS4-10089-14, CWS4-10090-14, CWS4-10091-14, CWS4-10092-14, CWS4-10093-14, CWS4-10094-14, CWS4-10095-14, CWS4-10096-14, CWS4-10201-15, CWS4-10206-15, CWS4-10207-15, CWS4-10208-15, CWS4-10209-15, CWS4-10210-15, CWS4-10211-15, CWS4-10212-15, CWS4-10213-15, CWS4-10214-15, CWS4-10215-15, CWS4-10216-15, CWS4-10217-15, CWS4-10218-15, CWS4-10219-15, CWS4-10220-15, CWS4-10221-15, CWS4-10222-15, CWS4-10223-15, CWS4-10245-15, CWS4-10246-15, CWS4-10247-15, CWS4-10248-15, CWS4-10249-15, CWS4-10250-15, CWS4-10251-15, CWS4-10252-15, CWS4-10253-15, CWS4-10254-15, CWS4-10255-15, CWS4-10256-15, CWS4-10257-15, CWS4-10258-15, CWS4-10259-15, CWS4-10260-15, CWS4-10261-15, CWS4-10262-15, CWS4-10263-15, CWS4-10264-15, CWS4-10265-15, CWS4-10266-15, CWS4-10267-15, CWS4-10268-15, CWS4-10269-15, CWS4-10270-15, CWS4-10271-15, CWS4-10272-15, CWS4-10273-15, CWS4-10274-15, CWS4-10275-15, CWS4-10276-15, CWS4-10277-15, CWS4-10278-15, CWS4-10280-15, CWS4-10281-15, CWS4-10282-15, CWS4-10283-15, CWS4-10284-15, CWS4-10285-15, CWS4-10286-15, CWS4-10287-15, CWS4-10288-15, CWS4-10289-15, CWS4-10290-15, CWS4-10291-15, CWS4-10292-15, CWS4-10293-15, CWS4-10294-15, CWS4-10295-15, CWS4-10296-15, CWS4-10297-15, CWS4-10298-15, CWS4-10299-15, CWS4-10300-15, CWS4-10301-15, CWS4-10302-15, CWS4-10304-15, CWS4-10305-15, CWS4-10306-15, CWS4-10307-15, CWS4-10308-15, CWS4-10309-15, CWS4-10310-15, CWS4-10311-15, CWS4-10312-15, CWS4-10313-15, CWS4-10314-15, CWS4-10315-15, CWS4-10316-15, CWS4-10317-15, CWS4-10318-15, CWS4-10319-15, CWS4-10320-15, CWS4-10321-15, CWS4-10322-15, CWS4-10323-15, CWS4-10325-15, CWS4-10326-15, CWS4-10327-15, CWS4-10328-15, CWS4-10329-15, CWS4-10330-15, CWS4-10331-15, CWS4-10332-15, CWS4-10333-15, CWS4-10334-15, CWS4-10335-15, CWS4-10336-15, CWS4-10337-15, CWS4-10338-15, CWS4-10339-15, CWS4-10340-15, CWS4-10341-15, CWS4-10342-15, CWS4-10343-15, CWS4-10344-15, CWS4-10345-15, CWS4-10346-15, CWS4-10347-15, CWS4-10348-15, CWS4-10349-15, CWS4-10350-15, CWS4-10351-15, CWS4-10352-15, CWS4-10353-15, CWS4-10354-15, CWS4-10355-15, CWS4-10356-15, CWS4-10357-15, CWS4-10358-15, CWS4-10359-15, CWS4-10360-15, CWS4-10361-15, CWS4-10362-15, CWS4-10363-15, CWS4-10364-15, CWS4-10365-15, CWS4-10366-15, CWS4-10367-15, CWS4-10368-15, CWS4-10369-15, CWS4-10370-15, CWS4-10371-15, CWS4-10372-15, CWS4-10373-15, CWS4-10374-15, CWS4-10375-15, CWS4-10376-15, CWS4-10377-15, CWS4-10378-15, CWS4-10379-15, CWS4-10382-15, CWS4-10383-15, CWS4-10384-15, CWS4-10385-15, CWS4-10386-15, CWS4-10387-15, CWS4-10388-15, CWS4-10389-15, CWS4-10390-15, CWS4-10391-15, CWS4-10392-15, CWS4-10393-15, CWS4-10394-15, CWS4-10395-15, CWS4-10396-15, CWS4-10397-15, CWS4-10398-15, CWS4-10401-15, CWS4-10421-15, CWS4-10434-15, CWS4-10435-15, CWS4-10436-15, CWS4-10437-15, CWS4-10438-15, CWS4-10439-15, CWS4-10440-15, CWS4-10441-15, CWS4-10442-15, CWS4-10443-15, CWS4-10444-15, CWS4-10445-15, CWS4-10446-15, CWS4-10447-15, CWS4-10448-15, CWS4-10449-15, CWS4-10450-15, CWS4-10451-15, CWS4-10457-15, CWS4-10458-15, CWS4-10459-15, CWS4-10460-15, CWS4-10461-15, CWS4-10462-15, CWS4-10463-15, CWS4-10464-15, CWS4-10465-15, CWS4-10466-15, CWS4-10467-15, CWS4-10468-15, CWS4-10469-15, CWS4-10470-15, CWS4-10471-15, CWS4-10472-15, CWS4-10473-15, CWS4-10474-15, CWS4-10475-15, CWS4-10476-15, CWS4-10477-15, CWS4-10478-15, CWS4-10479-15, CWS4-10480-15, CWS4-10481-15, CWS4-10482-15, CWS4-10483-15, CWS4-10484-15, CWS4-10485-15, CWS4-10486-15, CWS4-10487-15, CWS4-10488-15, CWS4-10489-15, CWS4-10490-15, CWS4-10491-15, CWS4-10492-15, CWS4-10493-15, CWS4-10494-15, CWS4-10495-15, CWS4-10496-15, CWS4-10497-15, CWS4-10498-15, CWS4-10499-15, CWS4-10500-15, CWS4-10501-15, CWS4-10502-15, CWS4-10503-15, CWS4-10504-15, CWS4-10505-15, CWS4-10506-15, CWS4-10507-15, CWS4-10508-15, CWS4-10509-15, CWS4-10510-15, CWS4-10511-15, CWS4-10512-15, CWS4-10513-15, CWS4-10514-15, CWS4-10515-15, CWS4-10516-15, CWS4-10517-15, CWS4-10518-15, CWS4-10519-15, CWS4-10520-15, CWS4-10521-15, CWS4-10522-15, CWS4-10523-15, CWS4-10524-15, CWS4-10525-15, CWS4-10526-15, CWS4-10527-15, CWS4-10528-15, CWS4-10529-15, CWS4-10530-15, CWS4-10531-15, CWS4-10532-15, CWS4-10533-15, CWS4-10534-15, CWS4-10535-15, CWS4-10536-15, CWS4-10537-15, CWS4-10538-15, CWS4-10539-15, CWS4-10540-15, CWS4-10541-15, CWS4-10542-15, CWS4-10543-15, CWS4-10544-15, CWS4-10545-15, CWS4-10546-15, CWS4-10547-15, CWS4-10549-15, CWS4-10550-15, CWS4-10551-15, CWS4-10552-15, CWS4-10553-15, CWS4-10554-15, CWS4-10555-15, CWS4-10556-15, CWS4-10557-15, CWS4-10558-15, CWS4-10559-15, CWS4-10560-15, WS4-10561-15, CWS4-10562-15, CWS4-10563-15, CWS4-10564-15, CWS4-10565-15, CWS4-10566-15, CWS4-10567-15, CWS4-10568-15, CWS4-10569-15, CWS4-10570-15, CWS4-10571-15, CWS4-10572-15, CWS4-10573-15, CWS4-10574-15, CWS4-10575-15, CWS4-10576-15, CWS4-10577-15, CWS4-10578-15, CWS4-10579-15, CWS4-10580-15, CWS4-10581-15, CWS4-10582-15, CWS4-10583-15, CWS4-10584-15, CWS4-10585-15, CWS4-10586-15, CWS4-10587-15, CWS4-10588-15, CWS4-10589-15, CWS4-10590-15, CWS4-10591-15, CWS4-10592-15, CWS4-10593-15, CWS4-10594-15, CWS4-10595-15, CWS4-10596-15, CWS4-10597-15, CWS4-10598-15, CWS4-10599-15, CWS4-10600-15, CWS4-10601-15, CWS4-10602-15, CWS4-10603-15, CWS4-10604-15, CWS4-10605-15, CWS4-10606-15, CWS4-10607-15, CWS4-10608-15, CWS4-10609-15, CWS4-10610-15, CWS4-10611-15, CWS4-10612-15, CWS4-10613-15, CWS4-10614-15, CWS4-10615-15, CWS4-10616-15, CWS4-10617-15, CWS4-10619-15, CWS4-10620-15, CWS4-10621-15, CWS4-10622-15, CWS4-10623-15, CWS4-10624-15, CWS4-10625-15, CWS4-10626-15, CWS4-10627-15, CWS4-10628-15, CWS4-10629-15, CWS4-10630-15, CWS4-10631-15, CWS4-10632-15, CWS4-10633-15, CWS4-10634-15, CWS4-10635-15, CWS4-10636-15, CWS4-10637-15, CWS4-10638-15, CWS4-10639-15, CWS4-10640-15, CWS4-10641-15, CWS4-10642-15, CWS4-10643-15, CWS4-10644-15, CWS4-10645-15, CWS4-10646-15, CWS4-10647-15, CWS4-10648-15, CWS4-10649-15, CWS4-10650-15, CWS4-10651-15, CWS4-10652-15, CWS4-10653-15, CWS4-10654-15, CWS4-10655-15, CWS4-10656-15, CWS4-10657-15, CWS4-10658-15, CWS4-10659-15, CWS4-10660-15, CWS4-10661-15, CWS4-10662-15, CWS4-10663-15, CWS4-10664-15, CWS4-10665-15, CWS4-10666-15, CWS4-10667-15, CWS4-10668-15, CWS4-10669-15, CWS4-10670-15, CWS4-10671-15, CWS4-10672-15, CWS4-10673-15, CWS4-10674-15, CWS4-10675-15, CWS4-10676-15, CWS4-10677-15m CWS4-10678-15, CWS4-10679-15, CWS4-10680-15m CWS4-10681-15, CWS4-10682-15, CWS4-10683-15, CWS4-10684-15, CWS4-10685-15, CWS4-10686-15, CWS4-10687-15, CWS4-10688-15, CWS4-10689-15, CWS4-10690-15, CWS4-10691-15, CWS4-10692-15, CWS4-10694-15, CWS4-10695-15, CWS4-10696-15, CWS4-10697-15, CWS4-10698-15, CWS4-10699-15, CWS4-10700-15, CWS4-10701-15, CWS4-10702-15, CWS4-10703-15, CWS4-10704-15, CWS4-10705-15, CWS4-10706-15, CWS4-10727-15, CWS4-10728-15, CWS4-10729-15, CWS4-10730-15, CWS4-10731-15, CWS4-10732-15, CWS4-10733-15, CWS4-10734-15, CWS4-10736-15, CWS4-10737-15, CWS4-10738-15, CWS4-10739-15, CWS4-10740-15, CWS4-10741-15, CWS4-10742-15, CWS4-10793-15, CWS4-10794-15, CWS4-10795-15, CWS4-10796-15, CWS4-10797-15, CWS4-10798-15, CWS4-10799-15, CWS4-10800-15, CWS4-10801-15, CWS4-10802-15, CWS4-10803-15, CWS4-10804-15, CWS4-10805-15, CWS4-10806-15, CWS4-10807-15, CWS4-10808-15, CWS4-10809-15, CWS4-10810-15, CWS4-10811-15, CWS4-10812-15, CWS4-10813-15, CWS4-10814-15, CWS4-10815-15, CWS4-10816-15, CWS4-10817-15, CWS4-10818-15, CWS4-10819-15, CWS4-10820-15, CWS4-10821-15, CWS4-10822-15, CWS4-10823-15, CWS4-10824-15, CWS4-10825-15, CWS4-10826-15, CWS4-10827-15, CWS4-10828-15, CWS4-10829-15, CWS4-10830-15, CWS4-10831-15, CWS4-10832-15, CWS4-10833-15, CWS4-10834-15, CWS4-10835-15, CWS4-10836-15, CWS4-10837-15, CWS4-10838-15, CWS4-10839-15, CWS4-10840-15, CWS4-10841-15, CWS4-10842-15, CWS4-10843-15, CWS4-10844-15, CWS4-10845-15, CWS4-10846-15, CWS4-10847-15, CWS4-10848-15, CWS4-10849-15, CWS4-10850-15, CWS4-10851-15, CWS4-10852-15, CWS4-10853-15, CWS4-10854-15, CWS4-10855-15, CWS4-10856-15, CWS4-10857-15, CWS4-10858-15, CWS4-10859-15, CWS4-10860-15, CWS4-10861-15, CWS4-10862-15, CWS4-10863-15, CWS4-10864-15, CWS4-10865-15, CWS4-10866-15, CWS4-10867-15, CWS4-10868-15, CWS4-5023-13, CWS4-5026-13, CWS4-5027-13, CWS4-5028-13, CWS4-5029-13, CWS4-5030-13, CWS4-5031-13, CWS4-5032-13, CWS4-5033-13, CWS4-5035-13, CWS4-5036-13, CWS4-5037-13, CWS4-5038-13, CWS4-5039-13, CWS4-5040-13, CWS4-5041-13, CWS4-5042-13, CWS4-5043-13, CWS4-5044-13, CWS4-5045-13, CWS4-5046-13, CWS4-5047-13, CWS4-5048-13, CWS4-5050-13, CWS4-5051-13, CWS4-5052-13, CWS4-5053-13, CWS4-5054-13, CWS4-5055-13, CWS4-5056-13, CWS4-5057-14, CWS4-5058-14, CWS4-5059-14, CWS4-5060-14, CWS4-5063-14, CWS4-5064-14, CWS4-5065-14, CWS4-5066-14, CWS4-5067-14, CWS4-5068-14, CWS4-5069-14, CWS4-5070-14, CWS4-5071-14, CWS4-5072-14, CWS4-5073-14, CWS4-5074-14, CWS4-5075-14, CWS4-5076-14, CWS4-5077-14, CWS4-5078-14, CWS4-5079-14, CWS4-5080-14, CWS4-5081-14, CWS4-5082-14, CWS4-5084-14, CWS4-5085-14, CWS4-5086-14, CWS4-5088-14, CWS4-5089-14, CWS4-5090-14, CWS4-5091-14, CWS4-5092-14, CWS4-5093-14, CWS4-5094-14, CWS4-5095-14, CWS4-5096-14, CWS4-5097-14, CWS4-5098-14, CWS4-5100-14, CWS4-5101-14
Where was it sold?
US Nationwide in the states of AZ CA FL GA KS LA MA MD MI MN NC NM NY OH PA QC SC TX VA WV and the Foreign distribution to Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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