510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-0986-2020Class II

Cocoon Convective Warming System

Care Essentials Pty., Ltd. / initiated 2020-01-07 / Terminated
FDA source (opens on fda.gov)

Care Essentials Pty., Ltd. began a recall of Cocoon Convective Warming System, Product Code: CWS4000 (110V) on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0986-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Care Essentials Pty., Ltd.
Product
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
Product code
DWJ System, Thermal Regulating
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.
FDA root cause
Other
Action
On January 7, 2020 the firm distributed Urgent Medical Device Recall Communication letters by FedEx stating: URGENT- Medical Device Field Correction Dear Valued Customer: Care Essentials (CE) is writing to advise you that, as a precautionary measure, we are issuing a voluntary product repair of CWS4000 and CWS5000 (110V) Cocoon Convective Warming Machines devices due to a report of thermal damage to the power entry module and power cord in a hospital in Canada. The affected devices were distributed in the U.S. from the date of March 3rd, 2015. There are no reported instances of death or serious injuries. However, in order to prevent a potential risk of fire, we are undertaking the following actions: - attaching a P-clip to the power cord of the device to both reduce the risk of using power cords that are not supplied or approved by Care Essentials, as well as reducing wear and tear of the power cord connector contacts from repeated plugging and unplugging; and - updating the instructions for use (IFU") to add warnings about avoiding unnecessary manipulation of the power cord connector, using only power cords (which have P-clips attached) supplied by Care Essentials, and not properly using a Care Essentials P-clipped power cord could lead to risk of fire. We ask that you: - Inspect devices cited in this notification letter for any damage to the power cord connector and power socket. If any damage is observed to these parts, please do not use the affected device and contact the undersigned for repair or replacement. - Ensure that this communication, including the updated IFU with highlighted revisions, is shared with all departments within the hospital/group of hospitals within your organization that may be using one of these devices. - Confirm receipt of this letter by email ([email protected] ), or [email protected]) or Telephone (703-9957179). Kindly fill and return the attached form: Medical Device Field Correction R
Quantity in commerce
689
Distribution
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.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0986-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0986-2020Class IITerminatedVoluntary: Firm initiated
Z-0987-2020Class IITerminatedVoluntary: Firm initiated