Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medline Probe Cover KitsCenturion

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-2205-2023
Recall Event ID 92466
Product Classification Orthopedic tray - Product Code OJH
Product Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) TOTAL JOINT, Model Number CDS985555S;
b) TOTAL KNEE, Model Number CDS985566Q;
c) MAJOR ORTHO-LF, Model Number DYNJ0949139I;
d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K;
e) BSHR TOTAL HIP-LF, Model Number DYNJ24526P;
f) TOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L;
g) TOTAL KNEE PACK 319735, Model Number DYNJ44635I;
h) HIP ARTHROPLASTY PACK, Model Number DYNJ50072F;
i) LEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L;
j) TOTAL JOINT, Model Number DYNJ57827D;
k) ANTERIOR HIP PACK, Model Number DYNJ59126B;
l) TOTAL HIP PACK, Model Number DYNJ60918A;
m) MAIN TOTAL JOINT, Model Number DYNJ61376C;
n) TOTAL HIP PACK, Model Number DYNJ63383;
o) ANTERIOR PACK, Model Number DYNJ64814A;
p) TOTAL JOINT PACK, Model Number DYNJ64951;
q) TOTAL KNEE PACK-EOSC, Model Number DYNJ65093B;
r) TOTAL KNEE PACK-CSC, Model Number DYNJ65108F;
s) MERCY ANTERIOR HIP, Model Number DYNJ66913A;
t) TOTAL PACK, Model Number DYNJ68468C;
u) TOTAL KNEE-LF, Model Number DYNJ69153F;
v) TOTAL JOINT PACK, Model Number DYNJ80372B;
w) ANTERIOR HIP PACK, Model Number DYNJ82038;
x) HIP PACK, Model Number DYNJ82345A;
y) TOTAL HIP PACK, Model Number DYNJ82627A;
z) TOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553;
aa) TOTAL JOINT PACK, Model Number DYNJ83567A;
bb) TOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885;
cc) HIP PACK, Model Number DYNJ84051;
dd) TOTAL KNEE PACK, Model Number DYNJ84054;
ee) OISC HAND KORCEK, Model Number DYNJ902351F;
ff) TOTAL HIP, Model Number DYNJ903149D;
gg) OISC TOTAL HIP BOTTROS, Model Number DYNJ904154O;
hh) TOTAL HIP, Model Number DYNJ904331I;
ii) TOTAL KNEE, Model Number DYNJ904332J;
jj) CRANIOTOMY, Model Number DYNJ905330B;
kk) TRAUMA-RAMA, Model Number DYNJ905886G;
ll) ANTERIOR HIP, Model Number DYNJ907831D;
mm) TOTAL HIP-LF, Model Number DYNJ908127B;
nn) TOTAL KNEE-LF, Model Number DYNJ908128B;
oo) TOTAL HIP CDS, Model Number DYNJ908331A;
pp) TOTAL KNEE THEDA, Model Number DYNJ908683A;
qq) TOTAL HIP-LF, Model Number DYNJ909000;
rr) TOTAL KNEE-LF, Model Number DYNJ909002;
ss) TOTAL HIP, Model Number DYNJ909198A;
tt) HIP MOFFIT PPS-LF, Model Number DYNJ9428703Q;
uu) LOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R;
vv) UPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O
Code Information a) Model Number CDS985555S, UDI/DI (EA) 10195327343798, UDI/DI (CS) 40195327343799; b) Model Number CDS985566Q, UDI/DI (EA) 10195327074418, UDI/DI (CS) 40195327074419; c) Model Number DYNJ0949139I, UDI/DI (EA) 10195327195366, UDI/DI (CS) 40195327195367; d) Model Number DYNJ24525K, UDI/DI (EA) 10195327135751, UDI/DI (CS) 40195327135752; e) Model Number DYNJ24526P, UDI/DI (EA) 10195327135744, UDI/DI (CS) 40195327135745; f) Model Number DYNJ26425L, UDI/DI (EA) 10195327156985, UDI/DI (CS) 40195327156986; g) Model Number DYNJ44635I, UDI/DI (EA) 10193489958553, UDI/DI (CS) 40193489958554; h) Model Number DYNJ50072F, UDI/DI (EA) 10193489340921, UDI/DI (CS) 40193489340922; i) Model Number DYNJ55655L, UDI/DI (EA) 10195327102029, UDI/DI (CS) 40195327102020; j) Model Number DYNJ57827D, UDI/DI (EA) 10193489910636, UDI/DI (CS) 40193489920637; k) Model Number DYNJ59126B, UDI/DI (EA) 10193489395983, UDI/DI (CS) 40193489395984; l) Model Number DYNJ60918A, UDI/DI (EA) 10193489257946, UDI/DI (CS) 40193489257947; m) Model Number DYNJ61376C, UDI/DI (EA) 10195327295066, UDI/DI (CS) 40195327295067; n) Model Number DYNJ63383, UDI/DI (EA) 10193489735109, UDI/DI (CS) 40193489735100; o) Model Number DYNJ64814A, UDI/DI (EA) 10195327112806, UDI/DI (CS) 40195327112807; p) Model Number DYNJ64951, UDI/DI (EA) 10193489236224, UDI/DI (CS) 40193489236225; q) Model Number DYNJ65093B, UDI/DI (EA) 10195327177508, UDI/DI (CS) 40195327177509; r) Model Number DYNJ65108F, UDI/DI (EA) 10195327256241, UDI/DI (CS) 40195327256242; s) Model Number DYNJ66913A, UDI/DI (EA) 10193489996234, UDI/DI (CS) 40193489996235; t) Model Number DYNJ68468C, UDI/DI (EA) 10195327097370, UDI/DI (CS) 40195327097371; u) Model Number DYNJ69153F, UDI/DI (EA) 10195327332679, UDI/DI (CS) 40195327332670; v) Model Number DYNJ80372B, UDI/DI (EA) 10195327244156, UDI/DI (CS) 40195327244157; w) Model Number DYNJ82038, UDI/DI (EA) 10195327163372, UDI/DI (CS) 40195327163373; x) Model Number DYNJ82345A, UDI/DI (EA) 10195327216556, UDI/DI (CS) 40195327316557; y) Model Number DYNJ82627A, UDI/DI (EA) 10195327333331, UDI/DI (CS) 40195327333332; z) Model Number DYNJ83553, UDI/DI (EA) 10195327279356, UDI/DI (CS) 40195327279357; aa) Model Number DYNJ83567A, UDI/DI (EA) 10195327343033, UDI/DI (CS) 40195327343034; bb) Model Number DYNJ83885, UDI/DI (EA) 10195327312237, UDI/DI (CS) 40195327312238; cc) Model Number DYNJ84051, UDI/DI (EA) 10195327330316, UDI/DI (CS) 40195327330317; dd) Model Number DYNJ84054, UDI/DI (EA) 10195327330347, UDI/DI (CS) 40195327330348; ee) Model Number DYNJ902351F, UDI/DI (EA) 10195327318420, UDI/DI (CS) 40195327318421; ff) Model Number DYNJ903149D, UDI/DI (EA) 10195327271139, UDI/DI (CS) 40195327261130; gg) Model Number DYNJ904154O, UDI/DI (EA) 10195327318604, UDI/DI (CS) 40195327318605; hh) Model Number DYNJ904331I, UDI/DI (EA) 10195327025700, UDI/DI (CS) 40195327025701; ii) Model Number DYNJ904332J, UDI/DI (EA) 10195327025694, UDI/DI (CS) 40195327025695; jj) Model Number DYNJ905330B, UDI/DI (EA) 10193489781502, UDI/DI (CS) 40193489781503; kk) Model Number DYNJ905886G, UDI/DI (EA) 10195327329167, UDI/DI (CS) 40195327329168; ll) Model Number DYNJ907831D, UDI/DI (EA) 10195327239701, UDI/DI (CS) 40195327239702; mm) Model Number DYNJ908127B, UDI/DI (EA) 10195327349929, UDI/DI (CS) 40195327349920; nn) Model Number DYNJ908128B, UDI/DI (EA) 10195327349912, UDI/DI (CS) 40195327349913; oo) Model Number DYNJ908331A, UDI/DI (EA) 10195327190156, UDI/DI (CS) 40195327190157; pp) Model Number DYNJ908683A, UDI/DI (EA) 10195327251772, UDI/DI (CS) 40195327251773; qq) Model Number DYNJ909000, UDI/DI (EA) 10195327238100, UDI/DI (CS) 40195327238101; rr) Model Number DYNJ909002, UDI/DI (EA) 10195327238148, UDI/DI (CS) 40195327238149; ss) Model Number DYNJ909198A, UDI/DI (EA) 10195327414788, UDI/DI (CS) 40195327414789; tt) Model Number DYNJ9428703Q, UDI/DI (EA) 10195327329174, UDI/DI (CS) 40195327329175; uu) Model Number DYNJ9428745R, UDI/DI (EA) 10195327258368, UDI/DI (CS) 40195327258369; vv) Model Number DYNJ9428787O, UDI/DI (EA) 10195327328795, UDI/DI (CS) 40195327328795; All lots within expiry, distributed from Medline between December 2017 - May 2023:
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 4500 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.
-
-