Z-0577-05

Cold Therapy Blanket

Name: Z-0577-05 Cold Therapy Blanket
Creator: DeRoyal Technologies Inc
Published: 2004-11-22
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2004-11-22 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Technologies Inc began a recall of Cold Therapy Blanket on 2004-11-22. The reason FDA records is "There is a possibility of water leaking from the welded seam of the blanket". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0577-05
Status: Terminated
Initiated: 2004-11-22
Posted: 2005-03-09
Terminated: 2005-09-13
Recalling firm: DeRoyal Industries, Inc.
Product: Cold Therapy Blanket
Product code: ILO Pack, Hot Or Cold, Water Circulating
Reason for recall: There is a possibility of water leaking from the welded seam of the blanket.
Root cause tag: manufacturing process
FDA root cause: Other
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.
Quantity in commerce: 5084 units
Distribution: Nationwide and Mexico VA Contrat FSS Contract #V797P-4352a (Sept 2002-2007) DoD Contract - DAPA Contract #SP0200-95H-5020 (continous)
Product codes and lots: 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 code ILO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)