ClearanceBrief
Recall Z-0577-05 ยท ILO Pack, Hot Or Cold, Water Circulating

DeRoyal Technologies Inc

Cold Therapy Blanket

DateMar 9, 2005 (initiated Nov 22, 2004)
StatusTerminated
ReasonThere is a possibility of water leaking from the welded seam of the blanket.
Root causeOther
ActionRecall notification was sent out via UPS 2nd day air on 11/22/2004 requesting return of the product and a sub recall if the product was further distributed.
Quantity5084 units
DistributionNationwide and Mexico VA Contrat FSS Contract #V797P-4352a (Sept 2002-2007) DoD Contract - DAPA Contract #SP0200-95H-5020 (continous)
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.