Medline Probe Cover Kits containing sterile Ultrasound recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b)…

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Quantity

55014 units

Distribution

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Recall date

July 26, 2023

Classification

Class II

Status

Ongoing

Agency

FDA (device)