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Credits
Manufacturers
Salter Laboratories, Division of Regulatory Affairs
Manufacturer Address
Salter Laboratories, Division of Regulatory Affairs, 100 Sycamore Rd, Arvin CA 93203-2300
Source
USFDA
8 Events
Recall of Device Recall Mask adult, elastic strap style, PercentO2 Lock air entrainment system
Recall of Device Recall Mask adult, oxygen, medium concentration, elastic strap
Recall of Device Recall Mask adult, oxygen, medium concentration, nonbreathing
Recall of Device Recall Mask adult, oxygen, medium concentration, elastic strap & nonbreathing
Recall of Device Recall Nebulizer
Recall of Device Recall ThermiSense model 5700A5
Recall of Salter Laboratories Adult Nasal Cannula
Recall of Nasal Cannula (Adult) Salter Style
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8 devices in the database
Device Recall Mask adult, elastic strap style, PercentO2 Lock air entrainment system
Model / Serial
Lot 022611; Product code: L150-7-50
Product Classification
Anesthesiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
Product Description
Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs; || Salter Labs, Arvin, CA 93203 || Intended usage: respiratory therapy.
Device Recall Mask adult, oxygen, medium concentration, elastic strap
Model / Serial
Lot 022811; Product code: E8110-7-50
Product Classification
Anesthesiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
Product Description
Mask adult, oxygen, medium concentration, elastic strap style, w/9' tube - 50/cs; || Salter Labs, Arvin, CA 93203 || Intended usage: respiratory therapy.
Device Recall Mask adult, oxygen, medium concentration, nonbreathing
Model / Serial
Lot 031411; Product code: 8130-9-25; Product code: 8130-0-50; Product Code: E8139-7-50.
Product Classification
Anesthesiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
Product Description
Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/9' tube and safety vent - 50/cs; || Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w safety vent - 50/cs; || Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/7' tube and safety vent - 50/cs; || Salter Labs, Arvin, CA 93203 || Intended usage: respiratory therapy.
Device Recall Mask adult, oxygen, medium concentration, elastic strap & nonbreathing
Model / Serial
Lot 030711; Product code: 8110-7-50, Product code: 8130-7-50; Product code: E8149-7-50.
Product Classification
Anesthesiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
Product Description
Mask adult, oxygen, medium concentration, elastic strap style w. 7' tube (Linde) 50/cs || Mask, adult, oxygen, high concentration, non-rebreathing, elastic strap style w/ 7' tube and safety vent - 50/cs; || Mask adult, oxygen, high concentration, non-rebreathing, w/7' tube w/out safety vent - 50/cs; || Salter Labs, Arvin, CA 93203 || Intended usage: respiratory therapy.
Device Recall Nebulizer
Model / Serial
Product code: 8924-7-50, Lot 022811
Product Classification
Anesthesiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
Product Description
Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free || Salter Labs, Arvin, CA 93203 || Intended usage: respiratory therapy.
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