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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Probe Cover Kits

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  Class 2 Device Recall Medline Probe Cover Kits see related information
Date Initiated by Firm May 18, 2023
Date Posted July 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-2156-2023
Recall Event ID 92466
Product Classification Spinal epidural anesthesia kit - Product Code OFT
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
Code Information 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;
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer Reason
for Recall		 Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
FDA Determined
Cause 2		 Device Design
Action Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704
Quantity in Commerce 28568 units
Distribution Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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