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MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ8
Recalled July 26, 2023 · FDA recall Z-2156-2023 · MEDLINE INDUSTRIES, LP - Northfield
Hazard
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. · FDA Class II
Units
28568 units
Sold at
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Description
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881; d) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881A; e) PAIN TRAY, Model Number DYNJRA1603; f) FEMORAL BLOCK TRAY, Model Number DYNJRA1739A; g) TAP BLOCK, Model Number DYNJRA1823; h) NERVE BLOCK PREP TRAY, Model Number DYNJRA1837; i) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA1847; j) ANESTHESIA BLOCK PACK - TBR, Model Number DYNJRA1864; k) 18G CPNB 20G STYLETED CATHETER, Model Number DYNJRA1869; l) NERVE BLOCK TRAY, Model Number DYNJRA1878; m) BLOCK KIT, Model Number DYNJRA1893; n) NERVE BLOCK TRAY, Model Number DYNJRA1900; o) US TPI KIT, Model Number DYNJRA1945; p) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA1975; q) DR LEWIS US TRAY, Model Number DYNJRA1998; r) ULTRASOUND GUIDED NERVE BLOCK, Model Number DYNJRA2013; s) ULTRASOUND TRAY, Model Number DYNJRA2022; t) NERVE BLOCK INSERTION, Model Number DYNJRA2027; u) PAIN PREP W/ PROBE COVER TRAY, Model Number DYNJRA2028; v) PAIN PREP W/ PROBE COVER TRAY, Model Number DYNJRA2028A; w) PAIN TRAY, Model Number DYNJRA2041; x) SUPPORT TRAY, Model Number DYNJRA2044; y) SUPERFICIAL NERVE BLOCK, Model Number DYNJRA2086; z) NERVE BLOCK TRAY, Model Number DYNJRA2148; aa) TRAY 18G CPNB 20G STYLETED, Model Number DYNJRA9040; bb) ULTRASOUND BLOCK TRAY, Model Number DYNJRA9044; cc) PERIPHERAL NERVE CATHETER KT, Model Number PAIN1560; dd) PAIN PREP W/PROBE COVER TRAY, Model Number PAIN1762
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →