RecallRadar

FDA Device recall Z-2293-2023

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-2293-2023
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.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA1864; d. BLOCK KIT, Model Number: DYNJRA1893; e. DR LEWIS US TRAY, Model Number: DYNJRA1998; f. ECHOGENIC SINGLE SHOT TRAY, Model Number: DYNJRA1978, DYNJRA1978A, SAMPA0109; g. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739A; h. NERVE BLOCK INSERTION, Model Number: DYNJRA2027; i. NERVE BLOCK PREP TRAY, Model Number: DYNJRA1837; j. NERVE BLOCK TRAY, Model Number: DYNJRA1878, DYNJRA1900; k. NERVE PERIPHERAL PACK, Model Number: DYNJRA2055; l. PAIN BLOCK TRAY, Model Number: DYNJRA0827A; m. PAIN PREP TRAY W/PROBE COVER, Model Numbers: DYNJRA0881, DYNJRA1847, DYNJRA1975; n. PAIN PREP W/ PROBE COVER TRAY, Model Number: DYNJRA2028; o. PAIN PREP W/PROBE COVER TRAY, Model Number: PAIN1762; p. PAIN TRAY, Model Number: DYNJRA1603; q. PERIPHERAL NERVE CATHETER KT, Model Number: PAIN1560; r. PREOP NERVE BLOCK TRAY, Model Number: DYNJRA2040; s. PREP TRAY, Model Number: DYNJRA1498A; t. SINGLE SHOT BLOCK, Model Number: DYNJRA0961B; u. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA2077; v. TAP BLOCK, Model Number: DYNJRA1823; w. TRAY ULTRASOUND BLOCK 20G X 4, Model Number: DYNJRA9044; x. TRAY 18G CPNB 20G STYLETED, Model Number: DYNJRA9040; y. ULTRASOUND TRAY, Model Number: DYNJRA2022; z. US TPI KIT, Model Number: DYNJRA1945

Reason

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

Identifiers

upc019532701881
upc019348966504
upc019348926312
upc019532706282
upc019532719429
upc019532732040
upc019532709698
upc019348992495
upc019532722522
upc019348997671
upc019532704037
upc019532708225
upc019532725516
upc019348921446
upc019348999366
upc019532716324
upc019348996209
upc019348929900
upc019348921538
upc019532724369
upc019532712905
upc019532726771
upc019532727891
upc019348996188
upc019348988811
upc019348983051
upc019532721816
upc019532713305
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: DYNJRA1869; UPC Number: 019532701881. b. Model Number: DYNJRA0949C; UPC Number: 019348966504. c. Model Number: DYNJRA1864; UPC Number: 019348926312. d. Model Number: DYNJRA1893; UPC Number: 019532706282. e. Model Number: DYNJRA1998; UPC Number: 019532719429. f. Model Number: DYNJRA1978, UPC Number: 019348926312; Model Number: DYNJRA1978A, UPC Number: 019532732040; Model Number: SAMPA0109, UPC Number: 019532709698. g. Model Number: DYNJRA1739A; UPC Number: 019348992495. h. Model Number: DYNJRA2027; UPC Number: 019532722522. i. Model Number: DYNJRA1837. UPC Number: 019348997671. j. Model Number: DYNJRA1878, UPC Number: 019532704037; Model Number: DYNJRA1900, UPC Number: 019532708225. k. Model Number: DYNJRA2055, UPC Number: 019532725516. l. Model Number: DYNJRA0827A, UPC Number: 019348921446. m. Model Number: DYNJRA0

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-2293-2023%22

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