medical Class II Updated 2023-08-09

MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Tu

Recalled Product

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;

Hazard / Issue

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ54287A, UPC Number: 088994276521. b. Model Number: DYNJ66190, UPC Number: 019348932219. c. Model Number: DYNJ905622C, UPC Number: 019348926350. d. Model Number: DYNJ901745J, UPC Number: 019348960482. e. Model Number: DYNJ63347A, UPC Number: 019348927806. f. Model Number: CDS983069G, UPC Number: 019348992392. g. Model Number: CDS983069I, UPC Number: 019532707186. h. Model Number: DYNJ47716B, UPC Number: 019348945453. i. Model Number: SYNJ910018A, UPC Number: 019348937418. j. Model Number: DYNJ67954A, UPC Number: 019348995714. k. Model Number: DYNJ65706, UPC Number: 019348928490. l. Model Number: DYNJ905340A, UPC Number: 019348950213. m. Model Number: DYNJ20495J, UPC Number: 019348956435. n. Model Number: DYNJ30245, UPC Number: 008019678769. o. Model Number: DYNJ43861D, UPC Number: 088994276328. p. Model Number: DYNJ63634A, UPC Number: 019532714304. q. Model Number: DYNJ44410F, UPC Number: 019348981154.

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