FDA-Device2023-08-09Class II
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model Number: DYNJ901745J; e. CENTRAL LINE INSERTION, Model Number: DYNJ63347A; f. CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; g. DBD-CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; h. DBD
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Affected count
3,431 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model Number: DYNJ901745J; e. CENTRAL LINE INSERTION, Model Number: DYNJ63347A; f. CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; g. DBD-CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; h. DBD-IR THYROID PACK THLUF642-LF, Model Number: DYNJ47716B; i. ENT FREE FLAP, Model Number: SYNJ910018A; j. ENT FREE FLAP PACK, Model Number: DYNJ67954A; k. FEM CAROTID PACK, Model Number: DYNJ65706; l. FLAP ENT FREE, Model Number: DYNJ905340A; m. FREE FLAP PACK-LF, Model Number: DYNJ20495J; n. PACK HEAD NECK, Model Number: DYNJ30245; o. SVMMC CAROTID PACK, Model Number: DYNJ43861D; p. TAVR FAIRFAX, Model Number: DYNJ63634A; q. VNUS TRAY, Model Number: DYNJ44410F;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2309-2023Don't want to check this manually?
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