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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-2159-2023
Recall Event ID 92466
Product Classification Angiography/angioplasty kit - Product Code OEQ
Product Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M;
b) ANGIOGRAPHY OR, Model Number CDS984944C;
c) ANGIOGRAM, Model Number DYNJ0149444M;
d) EP LAB DEVICE PACK-LF, Model Number DYNJ0160556D;
e) VASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AG;
f) ANGIO PACK-LF, Model Number DYNJ0373279M;
g) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121I;
h) IPMC ANGIOGRAPHY PACK-LF, Model Number DYNJ0806254D;
i) ANGIOGRAPHY PACK-LF, Model Number DYNJ0854485T;
j) ANGIO DRAPE PACK, Model Number DYNJ17624B;
k) DEPAUL ANGIO PACK, Model Number DYNJ19939M;
l) EP ANGIOGRAPHY PACK, Model Number DYNJ24225K;
m) ANGIOGRAPHY DRAPE PACK-LF, Model Number DYNJ28067G;
n) DASHTI-YAO NEURO ANGIO-LF, Model Number DYNJ33457C;
o) ANGIOGRAM TRAY, Model Number DYNJ33638K;
p) ANGIO PACK, Model Number DYNJ34361;
q) ANGIO/PICC PACK, Model Number DYNJ36049;
r) IR MINOR ANGIO PACK, Model Number DYNJ37665B;
s) ANGIO LEFT HEART PACK, Model Number DYNJ40632C;
t) MV-IR ANGIO DRAPE PACK-LF, Model Number DYNJ41553D;
u) CUSTOM ANGIO TRAY, Model Number DYNJ41649F;
v) FS ANGIO, Model Number DYNJ42499C;
w) ANGIO PACK, Model Number DYNJ42903B;
x) ANGIO PACK, Model Number DYNJ43661B;
y) ANGIOGRAPHY PACK, Model Number DYNJ44293D;
z) ANGIO DRAPE PACK, Model Number DYNJ44320F;
aa) ANGIOGRAM PACK, Model Number DYNJ45007;
bb) ANGIO BASIN SET, Model Number DYNJ46043F;
cc) ANGIO TRAY, Model Number DYNJ46153B;
dd) ANGIOGRAM PACK, Model Number DYNJ47004C;
ee) ANGIO PACK, Model Number DYNJ47226A;
ff) ANGIOGRAPHY PACK, Model Number DYNJ47906;
gg) ANGIO DRAPE SPEC PROC PACK-LF, Model Number DYNJ47951A;
hh) MH HOOD CARDIAC ANGIO, Model Number DYNJ49884F;
ii) ANGIO PACK, Model Number DYNJ50624A;
jj) ANGIO PACK, Model Number DYNJ51239A;
kk) ANGIO TRAY, Model Number DYNJ52121;
ll) ANGIO PACK-LF, Model Number DYNJ52898C;
mm) ANGIOGRAPHY PACK, Model Number DYNJ55252B;
nn) ANGIOGRAPHY PACK, Model Number DYNJ57498;
oo) PERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645B;
pp) GENERAL ANGIO PACK, Model Number DYNJ57760B;
qq) ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792A;
rr) ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792B;
ss) ANGIO PACK, Model Number DYNJ58126A;
tt) HH ANGIO PACK, Model Number DYNJ59465B;
uu) OR ANGIO PACK, Model Number DYNJ60319A;
vv) ANGIO PACK 2-A, Model Number DYNJ60507A;
ww) FEMORAL ANGIOGRAPY SET UP, Model Number DYNJ61015B;
xx) ANGIO PACK, Model Number DYNJ62299;
yy) CLOVIS CATH LAB PACK, Model Number DYNJ62379;
zz) ANGIO PACK, Model Number DYNJ62544;
aaa) ANGIO TRAY W/CHLORAPREP, Model Number DYNJ62742;
bbb) OR ANGIO PAC , Model Number DYNJ63976A;
ccc) SUNSHINE PAC , Model Number DYNJ64830;
ddd) ANGIO PAC , Model Number DYNJ65043A;
eee) CATH LAB PAC , Model Number DYNJ65185;
fff) ANGIOGRAPHY PACK, Model Number DYNJ65190C;
ggg) PACK,BASIC ANGIO, Model Number DYNJ65482A;
hhh) ANGIO PACK, Model Number DYNJ66398B;
iii) ANGIOGRAPHY PACK, Model Number DYNJ66476;
jjj) SURGERY ANGIO PACK-LF, Model Number DYNJ66500;
kkk) OR ANGIOGRAPHY PACK, Model Number DYNJ67245;
lll) ANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065A;
mmm) ANGIO TRAY, Model Number DYNJ68758;
nnn) ANGIO, Model Number DYNJ902507B;
ooo) ANGIOGRAPHY PACK, Model Number DYNJC2371G;
ppp) ANGIOGRAPHY DRAPE PACK, Model Number DYNJT2344B;
qqq) PEDI ANGIO PACK-LF, Model Number PHS41743D
Code Information all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number 00-401318M, UDI/DI (EA)10193489348750, UDI/DI (CS)40193489348751 b) Model Number CDS984944C, UDI/DI (EA)10889942172955, UDI/DI (CS)40889942172956 c) Model Number DYNJ0149444M, UDI/DI (EA)10193489432824, UDI/DI (CS)40193489432825 d) Model Number DYNJ0160556D, UDI/DI (EA)10193489207552, UDI/DI (CS)40193489207553 e) Model Number DYNJ0201109AG, UDI/DI (EA)10193489497267, UDI/DI (CS)40193489497268 f) Model Number DYNJ0373279M, UDI/DI (EA)10193489519020, UDI/DI (CS)40193489519021 g) Model Number DYNJ0429121I, UDI/DI (EA)10193489897494, UDI/DI (CS)40193489897495 h) Model Number DYNJ0806254D, UDI/DI (EA)10889942471164, UDI/DI (CS)40889942471165 i) Model Number DYNJ0854485T, UDI/DI (EA)10193489864199, UDI/DI (CS)40193489864190 j) Model Number DYNJ17624B, UDI/DI (EA)10193489867299, UDI/DI (CS)40193489867290 k) Model Number DYNJ19939M, UDI/DI (EA)10193489393248, UDI/DI (CS)40193489393249 l) Model Number DYNJ24225K, UDI/DI (EA)10889942510702, UDI/DI (CS)40889942510703 m) Model Number DYNJ28067G, UDI/DI (EA)10889942744299, UDI/DI (CS)40889942744290 n) Model Number DYNJ33457C, UDI/DI (EA)10193489461800, UDI/DI (CS)40193489461801 o) Model Number DYNJ33638K, UDI/DI (EA)10193489343281, UDI/DI (CS)40193489343282 p) Model Number DYNJ34361, UDI/DI (EA)10884389348475, UDI/DI (CS)40884389348476 q) Model Number DYNJ36049, UDI/DI (EA)10884389498675, UDI/DI (CS)40884389498676 r) Model Number DYNJ37665B, UDI/DI (EA)10889942969739, UDI/DI (CS)40889942969730 s) Model Number DYNJ40632C, UDI/DI (EA)10193489461176, UDI/DI (CS)40193489461177 t) Model Number DYNJ41553D, UDI/DI (EA)10889942811335, UDI/DI (CS)40889942811336 u) Model Number DYNJ41649F, UDI/DI (EA)10193489641271, UDI/DI (CS)40193489641272 v) Model Number DYNJ42499C, UDI/DI (EA)10195327030865, UDI/DI (CS)40195327030866 w) Model Number DYNJ42903B, UDI/DI (EA)10888277798014, UDI/DI (CS)40888277798015 x) Model Number DYNJ43661B, UDI/DI (EA)10889942808700, UDI/DI (CS)40889942808701 y) Model Number DYNJ44293D, UDI/DI (EA)10193489833416, UDI/DI (CS)40193489833417 z) Model Number DYNJ44320F, UDI/DI (EA)10193489435511, UDI/DI (CS)40193489435512 aa) Model Number DYNJ45007, UDI/DI (EA)10888277085411, UDI/DI (CS)40888277085412 bb) Model Number DYNJ46043F, UDI/DI (EA)10193489856729, UDI/DI (CS)40193489856720 cc) Model Number DYNJ46153B, UDI/DI (EA)10193489853643, UDI/DI (CS)40193489853644 dd) Model Number DYNJ47004C, UDI/DI (EA)10193489696172, UDI/DI (CS)40193489696173 ee) Model Number DYNJ47226A, UDI/DI (EA)10888277561816, UDI/DI (CS)40888277561817 ff) Model Number DYNJ47906, UDI/DI (EA)10888277528376, UDI/DI (CS)40888277528377 gg) Model Number DYNJ47951A, UDI/DI (EA)10193489609844, UDI/DI (CS)40193489609845 hh) Model Number DYNJ49884F, UDI/DI (EA)10193489469578, UDI/DI (CS)40193489469579 ii) Model Number DYNJ50624A, UDI/DI (EA)10889942474639, UDI/DI (CS)40889942474630 jj) Model Number DYNJ51239A, UDI/DI (EA)10889942493548, UDI/DI (CS)40889942493549 kk) Model Number DYNJ52121, UDI/DI (EA)10889942243624, UDI/DI (CS)40889942243625 ll) Model Number DYNJ52898C, UDI/DI (EA)10193489876314, UDI/DI (CS)40193489876315 mm) Model Number DYNJ55252B, UDI/DI (EA)10193489870152, UDI/DI (CS)40193489870153 nn) Model Number DYNJ57498, UDI/DI (EA)10889942745746, UDI/DI (CS)40889942745747 oo) Model Number DYNJ57645B, UDI/DI (EA)10193489828658, UDI/DI (CS)40193489828659 pp) Model Number DYNJ57760B, UDI/DI (EA)10193489342581, UDI/DI (CS)40193489342582 qq) Model Number DYNJ57792A, UDI/DI (EA)10193489530896, UDI/DI (CS)40193489530897 rr) Model Number DYNJ57792B, UDI/DI (EA)10193489845945, UDI/DI (CS)40193489845946 ss) Model Number DYNJ58126A, UDI/DI (EA)10193489484755, UDI/DI (CS)40193489484756 tt) Model Number DYNJ59465B, UDI/DI (EA)10193489470932, UDI/DI (CS)40193489470933 uu) Model Number DYNJ60319A, UDI/DI (EA)10193489276299, UDI/DI (CS)40193489276290 vv) Model Number DYNJ60507A, UDI/DI (EA)10193489830552, UDI/DI (CS)40193489830553 ww) Model Number DYNJ61015B, UDI/DI (EA)10193489368888, UDI/DI (CS)40193489368889 xx) Model Number DYNJ62299, UDI/DI (EA)10193489641516, UDI/DI (CS)40193489641517 yy) Model Number DYNJ62379, UDI/DI (EA)10193489651706, UDI/DI (CS)40193489651707 zz) Model Number DYNJ62544, UDI/DI (EA)10193489666526, UDI/DI (CS)40193489666527 aaa) Model Number DYNJ62742, UDI/DI (EA)10193489685923, UDI/DI (CS)40193489685924 bbb) Model Number DYNJ63976A, UDI/DI (EA)10193489377965, UDI/DI (CS)40193489377966 ccc) Model Number DYNJ64830, UDI/DI (EA)10193489223132, UDI/DI (CS)40193489223133 ddd) Model Number DYNJ65043A, UDI/DI (EA)10193489379327, UDI/DI (CS)40193489379328 eee) Model Number DYNJ65185, UDI/DI (EA)10193489253146, UDI/DI (CS)40193489253147 fff) Model Number DYNJ65190C, UDI/DI (EA)10193489433111, UDI/DI (CS)40193489433112 ggg) Model Number DYNJ65482A, UDI/DI (EA)10193489416824, UDI/DI (CS)40193489416825 hhh) Model Number DYNJ66398B, UDI/DI (EA)10193489891928, UDI/DI (CS)40193489891929 iii) Model Number DYNJ66476, UDI/DI (EA)10193489356779, UDI/DI (CS)40193489356770 jjj) Model Number DYNJ66500, UDI/DI (EA)10193489357912, UDI/DI (CS)40193489357913 kkk) Model Number DYNJ67245, UDI/DI (EA)10193489393057, UDI/DI (CS)40193489393058 lll) Model Number DYNJ68065A, UDI/DI (EA)10193489888720, UDI/DI (CS)40193489888721 mmm) Model Number DYNJ68758, UDI/DI (EA)10193489837568, UDI/DI (CS)40193489837569 nnn) Model Number DYNJ902507B, UDI/DI (EA)10889942781188, UDI/DI (CS)40889942781189 ooo) Model Number DYNJC2371G, UDI/DI (EA)10889942494675, UDI/DI (CS)40889942494676 ppp) Model Number DYNJT2344B, UDI/DI (EA)10889942107803, UDI/DI (CS)40889942107804 qqq) Model Number PHS41743D, UDI/DI (EA)10193489453270, UDI/DI (CS)40193489453271
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 55014 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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