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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-2200-2023
Recall Event ID 92466
Product Classification I.V. start kit - Product Code LRS
Product Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) ARTERIAL LINE START KIT , Model Number ART920;
b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005;
c) ULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006;
d) PIV BSI KIT , Model Number BSIPIV1010;
e) ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011;
f) PICC INSERTION TRAY , Model Number CVI3805;
g) PEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B;
h) CENTRAL LINE INSERTION TRAY , Model Number DT19810;
i) NEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A;
j) USG PIV KIT , Model Number DYNDV2536;
k) ULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547;
l) USG PIV KIT , Model Number DYNDV2567;
m) POLY MIDLINE KIT 4F SL , Model Number DYNJ68937A;
n) PICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB;
o) PICC KIT 5F DL PL MB , Model Number DYNJ70152MB;
p) MIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB;
q) MIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB;
r) ULTRASOUND GUIDED PIV KIT , Model Number IVS3420B;
s) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C;
t) FLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770;
u) ULTRASOUND GUIDED PIV KIT , Model Number IVS3900A;
v) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A;
w) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B;
x) ULTRASOUND GUIDED PIV KIT , Model Number IVS4005;
y) MIDLINE KIT 4F SL MB , Model Number MID0001;
z) MIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003;
aa) MIDLINE BUNDLE 4FR SL , Model Number MID0005;
bb) MIDLINE KIT 4F SL PL MB , Model Number PICC0009A;
cc) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010;
dd) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011;
ee) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012;
ff) PICC BUNDLE 5FR DL , Model Number PICC0013;
gg) VANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A;
hh) VANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A;
Code Information All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ART920, UDI/DI (EA) 10653160327899, UDI/DI (CS) 00653160327892; b) Model Number BSIPIV1005, UDI/DI (EA) 10193489198867, UDI/DI (CS) 20193489198864; c) Model Number BSIPIV1006, UDI/DI (EA) 10653160356936, UDI/DI (CS) 00653160356939; d) Model Number BSIPIV1010, UDI/DI (EA) 10653160356523, UDI/DI (CS) 00653160356526; e) Model Number BSIPIV1011, UDI/DI (EA) 10653160353317, UDI/DI (CS) 00653160353310; f) Model Number CVI3805, UDI/DI (EA) 10653160265085, UDI/DI (CS) 00653160265088; g) Model Number CVI4450B, UDI/DI (EA) 10653160358428, UDI/DI (CS) 00653160358421; h) Model Number DT19810, UDI/DI (EA) 10653160285656, UDI/DI (CS) 00653160285659; i) Model Number DYNDA2509A, UDI/DI (EA) 10193489196986, UDI/DI (CS) 20193489196983; j) Model Number DYNDV2536, UDI/DI (EA) 10653160353676, UDI/DI (CS) 00653160353679; k) Model Number DYNDV2547, UDI/DI (EA) 10653160354246, UDI/DI (CS) 00653160354249; l) Model Number DYNDV2567, UDI/DI (EA) 10653160356455, UDI/DI (CS) 00653160356458; m) Model Number DYNJ68937A, UDI/DI (EA) 10193489111545, UDI/DI (CS) 20193489111542; n) Model Number DYNJ70141MB, UDI/DI (EA) 10889942722808, UDI/DI (CS) 20889942722805; o) Model Number DYNJ70152MB, UDI/DI (EA) 10889942722822, UDI/DI (CS) 40889942722823; p) Model Number DYNJ80141MB, UDI/DI (EA) 10889942733415, UDI/DI (CS) 20889942733412; q) Model Number DYNJ80152MB, UDI/DI (EA) 10889942733422, UDI/DI (CS) 20889942733429; r) Model Number IVS3420B, UDI/DI (EA) 10653160359067, UDI/DI (CS) 00653160359060; s) Model Number IVS3635C, UDI/DI (EA) 10653160358954, UDI/DI (CS) 00653160358957; t) Model Number IVS3770, UDI/DI (EA) 10653160328230, UDI/DI (CS) 00653160328233; u) Model Number IVS3900A, UDI/DI (EA) 10653160347774, UDI/DI (CS) 00653160347777; v) Model Number IVS3940A, UDI/DI (EA) 10653160345664, UDI/DI (CS) 00653160345667; w) Model Number IVS3940B, UDI/DI (EA) 10653160355335, UDI/DI (CS) 00653160355338; x) Model Number IVS4005, UDI/DI (EA) 10653160346142, UDI/DI (CS) 00653160346145; y) Model Number MID0001, UDI/DI (EA) 10193489381627, UDI/DI (CS) 40193489381628; z) Model Number MID0003, UDI/DI (EA) 10653160349334, UDI/DI (CS) 00653160349337; aa) Model Number MID0005, UDI/DI (EA) 10653160349181, UDI/DI (CS) 00653160349184; bb) Model Number PICC0009A, UDI/DI (EA) 10193489760231, UDI/DI (CS) 20193489760238; cc) Model Number PICC0010, UDI/DI (EA) 10653160349112, UDI/DI (CS) 00653160349115; dd) Model Number PICC0011, UDI/DI (EA) 10653160350842, UDI/DI (CS) 00653160350845; ee) Model Number PICC0012, UDI/DI (EA) 10653160350491, UDI/DI (CS) 00653160350494; ff) Model Number PICC0013, UDI/DI (EA) 10653160351818, UDI/DI (CS) 00653160351811; gg) Model Number STCVC2015A, UDI/DI (EA) 10653160350552, UDI/DI (CS) 00653160350555; hh) Model Number STCVC2020A, UDI/DI (EA) 10653160350569, UDI/DI (CS) 00653160350562
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 70648 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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