DJO, LLC recalls This is an accessory to Intelect Advanced, Intelect Mobile,
Recalled Product
This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient.
Hazard / Issue
The device accessories were not labeled with appropriate latex warning.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Part Number/ Description: 10679/ NYLATEX 4X36 PKG SING FOR UNIT 10827/ NYLATEX 2-1/2 X 18 CUT 10828/ NYLATEX 2-1/2X18 SEWN 10829/ NYLATEX 2-1/2X36 CUT 10830/ NYLATEX 2-1/2X36 SEWN 10831/ NYLATEX 2-1/2X48 CUT 10832/ NYLATEX 2-1/2X48 SEWN 10833/ NYLATEX 4X18 CUT 10834/ NYLATEX 4X18 SEWN 10835/ NYLATEX 4X36 CUT 10836/ NYLATEX 4X36 SEWN 10837/ NYLATEX 4X48 CUT 10838/ NYLATEX 4X48 SEWN 10839/ NYLATEX 6X18 CUT 10840/ NYLATEX 6X18 SEWN 10841/ NYLATEX 6X36 CUT 10842/ NYLATEX 6X36 SEWN 10843/ NYLATEX 6X48 CUT 10844/ NYLATEX 6X48 SEWN 12-0248-8/ NYLATEX 2-1/2X24 CUT 1210CHT/ NYLATEX 4X36 BAG OF 3 1214CHT/ NYLATEX 6X18 BAG OF 3 1213CHT/ NYLATEX 4X60 BAG OF 3 19991/ NYLATEX 6X60 CUT 19992 /NYLATEX 6X60 SEWN 19993/ NYLATEX 4X60 CUT 19994/ NYLATEX 4X60 SEWN 25-10648/ NYLATEX 2-1/2X24 25-10679/ NYLATEX 4X36 12-10648/ NYLATEX 2-1/2 X 24 SEWN 12-8655/ ASSY,STIM MODULE CH 3/4 INT'L PKG 3448274/ C-5 220-240V OEM ENRAF W/PKS 2778-10/ INTELECT MOBILE COMBO, INT'L STD, 10CM APPL 2777/ INTELECT MOBILE 2CH STIMINT'L STD 2778/ INTELECT MOBILE COMBO, INT'L STD, 5CM APPL 2778-2/ INTELECT MOBILE COMBO, INT'L STD, 2CM APPL 5951/ INTELECT VITALSTIM 2 CHANNEL THERAPY SYSTEM, INT'L STD 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD 2762CC/ INT ADV 2CH COLOR COMBO, INT'L 5CM APPL 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD 2755CS/ INT ADV 2CH COLOR STIM INT'L STD 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD, 2CM APPL 2765CS/ INT ADV 2CH COLOR STIM W/EMG INTL STD 2773MS/ INT ADVANCED STIM MONOCHROME INT'L STD 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD, 10CM APPL 2770/ STIM MODULE CH 3/4 INT'L PKG 3102/ C-5 120V PKG A 3114/ C-5 220V PKG A INT'L STD 1200/ NYLATEX INTRO PACK 1202/ NYLATEX 2-1/2X18 BAG OF 3* 1204/ NYLATEX 2-1/2X36 BAG OF 3* 1206/ NYLATEX 2-1/2X48 BAG OF 3* 1208/ NYLATEX 4X18 BAG OF 3* 1210/ NYLATEX 4X36 BAG OF 3* 1212/ NYLATEX 4X48 BAG OF 3* 1213/ NYLATEX 4X60 BAG OF 3* 1214/ NYLATEX 6X18 BAG OF 3* 1216/ NYLATEX 6X36 BAG OF 3* 1218/ NYLATEX 6X48 BAG OF 3* 1219/ NYLATEX 6X60 BAG OF 3 1264/ NYLATEX 2-1/2X24 BAG OF 3* 10648/ NYLATEX 2-1/2X24 SEWN 28099/ KIT, LEAD IN MOBILE STIM INTL 59048/ KIT LEAD STIM INT CLINIC VITLS (CH 1/2) 27378/ KIT LEAD INT ADVANCED 2CH 27509/ KIT LED 4CH EPR INT L