RecallRadar

FDA Device recall Z-2309-2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel

On 2023-08-09 the FDA classified a Class II recall of Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel by Medline Industries Northfield, citing potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2309-2023
ClassificationClass II
Statusongoing
Initiated2023-05-15
Published2023-08-09
Last updated2026-09-13 11:56 UTC
CompanyMedline Industries Northfield
DistributionUS

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;

Reason

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

Identifiers

upc088994276521
upc019348932219
upc019348926350
upc019348960482
upc019348927806
upc019348992392
upc019532707186
upc019348945453
upc019348937418
upc019348995714
upc019348928490
upc019348950213
upc019348956435
upc008019678769
upc088994276328
upc019532714304
upc019348981154
code_info
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2…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:

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2309-2023%22

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