Events

Recall of Device Recall Cold Therapy Blanket

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DeRoyal Technologies Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30701
  • Event Risk Class
    Class 2
  • Event Number
    Z-0577-05
  • Event Initiated Date
    2004-11-22
  • Event Date Posted
    2005-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36418
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pack, Hot Or Cold, Water Circulating - Product Code ILO
  • Reason
    There is a possibility of water leaking from the welded seam of the blanket.
  • Action
    Recall 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.

Device

Device Recall Cold Therapy Blanket
  • Model / Serial
    Item No. T230ST  Codes: 2797009, 3030109, 3403577  Item No. T330ST  Codes: 2930674, 3030125, 3058048, 3138849, 3139008, 3153547, 3316254, 3373996, 3432079, 3754300, 3754300  Item No. T332ST  Codes: 2031177, 2031185, 2797041, 3007785, 3010351, 3086698, 3088511, 3139024, 3213845, 3223980, 3316262, 3355991, 3410312, 3454500, 3531421, 3632046, 3678554,   Item No. T332VQ  Codes: 3138857, 3139032, 3357700, 3521805, 3531448  Item No. T333ST  Codes: 3018628, 3088520, 3155999, 3239471, 3285419, 3356002, 3403614, 3632054, 3670211  Item No. T333VQ  Codes: 2920450, 3030168, 3315631, 3440255, 3592970, 3614315  Item No. T350VQ  Codes: 2847395, 3207429, 3315649, 3592988, 3613574  Item No. T5030ST  Codes: 2930578, 3029950, 3043014, 3239244, 3282728, 3355894, 3403518  Item No. T5030ST-10  Code: 3678431  Item No. T5031ST  Codes: 3057791, 3138902, 3153512, 3239287, 3284491, 3316060, 3373793, 3431990, 3451771, 3505961, 3545436, 3580557, 3631941, 3647871, 3659901, 3668698, 3713647   Item No. T5031ST-10  Codes: 3315622, 3329776  Item No. T5032ST  Codes: 2852864, 2975696, 3088431, 3316107, 3373831, 3401951, 3410208, 3451780, 3531392, 3580581, 3678458  Item No. T5032ST-10  Codes: 2796891, 3009115, 3086680, 3194293, 3207402, 3223947, 3373849, 3631991  Item No. T5032VQ  Codes: 2796903, 2975717, 3138937, 3239332, 3316115, 3373857, 3432028, 3531405, 3580590, 3647918  Item No. T5033ST  Codes: 2904636, 2975750, 3153539, 3194314, 3239359, 3316131, 3355923, 3373873, 3432036, 3449022, 3451798, 3647926, 3698598  Item No. T5033ST-10  Codes: 3030037, 3088458, 3088466, 3239367, 3285355, 3355931, 3403542, 3454462, 3521813, 3532900, 3596436, 3632003  Item No. T5033VQ  Codes: 2678801, 3239375, 3316140, 3401969, 3505995, 3531413, 3580602, 3647977  Item No. T5040ST  Codes: 2181491, 2320147, 2371278, 2430477, 2496871, 2678819, 2904644, 2994521, 3030045, 3088491, 3138953, 3194541, 3239383, 3254495, 3285363, 3440221, 3592937, 3632011, 3678466  Item No. T5050ST  Codes: 2736169, 2753701, 2796954, 2897325, 2975805, 3030053, 3057900, 3194322, 3239404, 3316174, 3449031, 3451827, 3506040, 3713663  Item No. T5050ST-10  Codes: 1909831, 2975821, 3057942, 3316182  Item No. T5050VQ  Codes: 2678827, 2796971, 3057951, 3316191, 3647993  Item No. T5090ST  Codes: 2812011, 2897253  Item No. T530ST  Codes: 2930682, 3030176, 3058072, 3402048  Item No. T531ST  Code: 3402081  Item No. T533ST  Codes: 2753831, 3088554, 3402128  Item No. T540ST  Code: 2215216  Item No. T590ST  Codes: 1910081, 2320059, 2326485
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Mexico VA Contrat FSS Contract #V797P-4352a (Sept 2002-2007) DoD Contract - DAPA Contract #SP0200-95H-5020 (continous)
  • Product Description
    Cold Therapy Blanket
  • Manufacturer
    DeRoyal Technologies Inc

Manufacturer

DeRoyal Technologies Inc
  • Manufacturer Address
    DeRoyal Technologies Inc, 1595 Highway 33 South, New Tazewell TN 37825-7105
  • Source
    USFDA