Recall archive / FDA device enforcement
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPN... — FDA record Z-2293-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 29,277 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2293-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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: DYNJRA0881, UPC Number: 019348926312; Model Number: DYNJRA1847, UPC Number: 019348999366; Model Number: DYNJRA1975, UPC Number: 019532716324. n. Model Number: DYNJRA2028, UPC Number: 019348926312. o. Model Number: PAIN1762, UPC Number: 019348996209. p. Model Number: DYNJRA1603, UPC Number: 019348929900. q. Model Number: PAIN1560, UPC Number: 019348921538. r. Model Number: DYNJRA2040, UPC Number: 019532724369. s. Model Number: DYNJRA1498A, UPC Number: 019532712905. t. Model Number: DYNJRA0961B, UPC Number: 019532726771. u. Model Number: DYNJRA2077, UPC Number: 019532727891. v. Model Number: DYNJRA1823, UPC Number: 019348996188. w. Model Number: DYNJRA9044, UPC Number: 019348988811. x. Model Number: DYNJRA9040, UPC Number: 019348983051. y. Model Number: DYNJRA2022, UPC Number: 019532721816. z. Model Number: DYNJRA1945, UPC Number: 019532713305. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 9, 2023
- Recall initiation date
- May 15, 2023
- Center classification date
- Aug 3, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.