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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Probe Cover KitsCenturion

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  Class 2 Device Recall Medline Probe Cover KitsCenturion see related information
Date Initiated by Firm May 18, 2023
Date Posted July 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-2199-2023
Recall Event ID 92466
Product Classification Tray, surgical - Product Code LRP
Product Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005;
b) 20GX6" FEMORAL ART LINE KIT, Model Number ART1165;
c) 3" RADIAL ARTERIAL LINE KIT, Model Number ART240A;
d) 6" FEMORAL ARTERIAL LINE KIT, Model Number ART245A;
e) 6" FEMORAL ARTERIAL LINE KIT, Model Number ART245B;
f) ARTERIAL LINE BUNDLE, Model Number ART255;
g) ARTERIAL LINE BUNDLE, Model Number ART560;
h) A LINE TRAY, Model Number ART690;
i) ARTERIAL LINE TRAY, Model Number ART840;
j) 18GX6" FEMORAL ART LINE KIT, Model Number ART960;
k) 20Gx3" RADIAL ART LINE KIT, Model Number ART970;
l) BIOPSY/ASPIRATION TRAY, Model Number BT235A;
m) PERCUTANEOUS CHEST TUBE KIT, Model Number CHT1825;
n) PICC INSERTION KIT, Model Number CVI3735;
o) PICC INSERTION BUNDLE, Model Number CVI4025A;
p) VASCULAR ACCESS INSERTION KIT, Model Number CVI4180;
q) VASCULAR ACCESS INSERT KIT-PEDIATRICS, Model Number CVI4265;
r) UNIVERSAL CVC ZONE DEFENSE BUNDLE, Model Number CVI4430;
s) PEDIATRIC PICC INSERTION TRAY, Model Number CVI4450A;
t) CVC ACCESSORY BUNDLE, Model Number CVI4505;
u) DIALYSIS/CVC BUNDLE W/O CATHETER, Model Number CVI4655;
v) FISHLINE KIT, Model Number CVI4725;
w) VENOUS ACCESS TRAY, Model Number CVI4830A;
x) VENOUS ACCESS TRAY, Model Number CVI4830B;
y) CVC INSERTION BUNDLE- ADD A CATHETER, Model Number CVI4905;
z) MVHS CVC LUMEN TRAY, Model Number CVI4920;
aa) ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number DT22570A;
bb) ADULT VASCULAR ACCESS BUNDLE, Model Number DT22860;
cc) TOTE MCADAMS OSC SHLDR ARTHRO, Model Number DYKM1790A;
dd) MAX BARRIER KIT, Model Number DYND2673B;
ee) THYROID FNA TRAY, Model Number DYNDA2238A;
ff) PARA/THORACENTESIS TRAY, Model Number DYNDH1470B;
gg) BASIC BIOPSY TRAY, Model Number DYNDH1534;
hh) ULTRASOUND BIOPSY, Model Number DYNDH1542;
ii) BIOPSY TRAY, Model Number DYNDH1661;
jj) USG PIV KIT, Model Number DYNDV2536A;
kk) ULTRASOUND IV ACCESS PACK - LF, Model Number DYNJ0182378B;
ll) PORT INSERTION KIT, Model Number MNS11590;
mm) RADIOLOGY TRAY, Model Number MNS11625;
nn) BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number MNS12065;
oo) INTRA PROBE COVER 5X96 KIT, Model Number P155598;
pp) ULTRASOUND PROBE KIT, Model Number P482986;
qq) ARTHROGRAM TRAY, Model Number SPEC0232;
rr) ULTRA CORE BIOPSY KIT, Model Number SPEC0291B;
Code Information All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ART1005, UDI/DI (EA) 10193489198232, UDI/DI (CS) 20193489198239; b) Model Number ART1165, UDI/DI (EA) 10653160354680, UDI/DI (CS) 00653160354683; c) Model Number ART240A, UDI/DI (EA) 10653160328025, UDI/DI (CS) 00653160328028; d) Model Number ART245A, UDI/DI (EA) 10653160328018, UDI/DI (CS) 00653160328011; e) Model Number ART245B, UDI/DI (EA) 10653160358442, UDI/DI (CS) 00653160358445; f) Model Number ART255, UDI/DI (EA) 10653160311997, UDI/DI (CS) 00653160311990; g) Model Number ART560, UDI/DI (EA) 10653160310822, UDI/DI (CS) 00653160310825; h) Model Number ART690, UDI/DI (EA) 10653160318019, UDI/DI (CS) 00653160318012; i) Model Number ART840, UDI/DI (EA) 10653160322924, UDI/DI (CS) 00653160322927; j) Model Number ART960, UDI/DI (EA) 10193489190915, UDI/DI (CS) 20193489190912; k) Model Number ART970, UDI/DI (EA) 10193489190922, UDI/DI (CS) 20193489190929; l) Model Number BT235A, UDI/DI (EA) 10653160315919, UDI/DI (CS) 00653160315912; m) Model Number CHT1825, UDI/DI (EA) 10653160328988, UDI/DI (CS) 00653160328981; n) Model Number CVI3735, UDI/DI (EA) 10653160261544, UDI/DI (CS) 00653160261547; o) Model Number CVI4025A, UDI/DI (EA) 10193489396058, UDI/DI (CS) 40193489396059; p) Model Number CVI4180, UDI/DI (EA) 10653160284451, UDI/DI (CS) 00653160284454; q) Model Number CVI4265, UDI/DI (EA) 10653160291268, UDI/DI (CS) 00653160291261; r) Model Number CVI4430, UDI/DI (EA) 10653160314370, UDI/DI (CS) 00653160314373; s) Model Number CVI4450A, UDI/DI (EA) 10653160320517, UDI/DI (CS) 00653160320510; t) Model Number CVI4505, UDI/DI (EA) 10653160319047, UDI/DI (CS) 00653160319040; u) Model Number CVI4655, UDI/DI (EA) 10193489190373, UDI/DI (CS) 20193489190370; v) Model Number CVI4725, UDI/DI (EA) 10193489199871, UDI/DI (CS) 20193489199878; w) Model Number CVI4830A, UDI/DI (EA) 10653160353553, UDI/DI (CS) 00653160353556; x) Model Number CVI4830B, UDI/DI (EA) 10653160358534, UDI/DI (CS) 00653160358537; y) Model Number CVI4905, UDI/DI (EA) 10653160355618, UDI/DI (CS) 00653160355611; z) Model Number CVI4920, UDI/DI (EA) 10653160355847, UDI/DI (CS) 00653160355840; aa) Model Number DT22570A, UDI/DI (EA) 10653160346074, UDI/DI (CS) 00653160346077; bb) Model Number DT22860, UDI/DI (EA) 10653160359142, UDI/DI (CS) 00653160359145; cc) Model Number DYKM1790A, UDI/DI (EA) 10193489112412, UDI/DI (CS) 20193489112419; dd) Model Number DYND2673B, UDI/DI (EA) 10193489191394, UDI/DI (CS) 20193489191391; ee) Model Number DYNDA2238A, UDI/DI (EA) 10193489191554, UDI/DI (CS) 20193489191551; ff) Model Number DYNDH1470B, UDI/DI (EA) 10193489111248, UDI/DI (CS) 20193489111245; gg) Model Number DYNDH1534, UDI/DI (EA) 10193489197082, UDI/DI (CS) 20193489197089; hh) Model Number DYNDH1542, UDI/DI (EA) 10193489197396, UDI/DI (CS) 20193489197393; ii) Model Number DYNDH1661, UDI/DI (EA) 10193489111521, UDI/DI (CS) 20193489111528; jj) Model Number DYNDV2536A, UDI/DI (EA) 10653160357872, UDI/DI (CS) 00653160357875; kk) Model Number DYNJ0182378B, UDI/DI (EA) 10653160338536, UDI/DI (CS) 00653160338539; ll) Model Number MNS11590, UDI/DI (EA) 10653160321293, UDI/DI (CS) 00653160321296; mm) Model Number MNS11625, UDI/DI (EA) 10653160322139, UDI/DI (CS) 00653160322132; nn) Model Number MNS12065, UDI/DI (EA) 10653160331193, UDI/DI (CS) 00653160331196; oo) Model Number P155598, UDI/DI (EA) 10888277902237, UDI/DI (CS) 40888277902238; pp) Model Number P482986, UDI/DI (EA) 10888277903630, UDI/DI (CS) 40888277903631; qq) Model Number SPEC0232, UDI/DI (EA) 10888277507418, UDI/DI (CS) 40888277507419; rr) Model Number SPEC0291B, UDI/DI (EA) 10889942453054, UDI/DI (CS) 40889942453055;
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 39391 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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