Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ8

Summary

The FDA issued a Class II for Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo by MEDLINE INDUSTRIES, LP - Northfield. Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams..

Details

Product Description

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

Lot/Code Info: all lots within expiry, distributed from Medline between December 2017 1 May 2023: a) Model Number DYNJ81722, UDI/DI (EA) 10195327136437, UDI/DI (CS)40195327136438; b) Model Number DYNJRA0827A, UDI/DI (EA) 10193489214468, UDI/DI (CS)40193489214469; c) Model Number DYNJRA0881, UDI/DI (EA) 10889942463930, UDI/DI (CS)40889942463931; d) Model Number DYNJRA0881A, UDI/DI (EA) 10195327262402, UDI/DI (CS)40195327262403; e) Model Number DYNJRA1603, UDI/DI (EA) 10193489299007, UDI/DI (CS)40193489299008; f) Model Number DYNJRA1739A, UDI/DI (EA) 10193489924954, UDI/DI (CS)40193489924955; g) Model Number DYNJRA1823, UDI/DI (EA) 10193489961881, UDI/DI (CS)40193489961882; h) Model Number DYNJRA1837, UDI/DI (EA) 10193489976717, UDI/DI (CS)40193489976718; i) Model Number DYNJRA1847, UDI/DI (EA) 10193489993660, UDI/DI (CS)40193489993661; j) Model Number DYNJRA1864, UDI/DI (EA) 10195327008789, UDI/DI (CS)40195327008780; k) Model Number DYNJRA1869, UDI/DI (EA) 10195327018818, UDI/DI (CS)40195327018819; l) Model Number DYNJRA1878, UDI/DI (EA) 10195327040376, UDI/DI (CS)40195327040377; m) Model Number DYNJRA1893, UDI/DI (EA) 10195327062828, UDI/DI (CS)40195327062829; n) Model Number DYNJRA1900, UDI/DI (EA) 10195327082253, UDI/DI (CS)40195327082254; o) Model Number DYNJRA1945, UDI/DI (EA) 10195327133054, UDI/DI (CS)40195327133055; p) Model Number DYNJRA1975, UDI/DI (EA) 10195327163242, UDI/DI (CS)40195327163243; q) Model Number DYNJRA1998, UDI/DI (EA) 10195327194291, UDI/DI (CS)40195327194292; r) Model Number DYNJRA2013, UDI/DI (EA) 10195327212049, UDI/DI (CS)40195327212040; s) Model Number DYNJRA2022, UDI/DI (EA) 10195327218164, UDI/DI (CS)40195327218165; t) Model Number DYNJRA2027, UDI/DI (EA) 10195327225223, UDI/DI (CS)40195327225224; u) Model Number DYNJRA2028, UDI/DI (EA) 10195327226299, UDI/DI (CS)40195327226290; v) Model Number DYNJRA2028A, UDI/DI (EA) 10195327352042, UDI/DI (CS)40195327352043; w) Model Number DYNJRA2041, UDI/DI (EA) 10195327243708, UDI/DI (CS)40195327243709; x) Model Number DYNJRA2044, UDI/DI (EA) 10195327247300, UDI/DI (CS)40195327247301; y) Model Number DYNJRA2086, UDI/DI (EA) 10195327286750, UDI/DI (CS)40195327286751; z) Model Number DYNJRA2148, UDI/DI (EA) 10195327363758, UDI/DI (CS)40195327363759; aa) Model Number DYNJRA9040, UDI/DI (EA) 10193489830514, UDI/DI (CS)40193489830515; bb) Model Number DYNJRA9044, UDI/DI (EA) 10193489888119, UDI/DI (CS)40193489888110; cc) Model Number PAIN1560, UDI/DI (EA) 10193489215380, UDI/DI (CS)40193489215381; dd) Model Number PAIN1762, UDI/DI (EA) 10193489962093, UDI/DI (CS)40193489962094;

Quantity Affected: 28568 units

Reason for Recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-05-18

Company